MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-22 for ABBOTT M2000RT INSTRUMENT 09K15-01 manufactured by Abbott Molecular, Inc..
[103172034]
An elevated complaint investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[103172035]
The abbott m2000 realtime system is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the abbott m2000sp and abbott m2000rt instruments. The abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The abbott m2000rt is an automated system for performing fluorescence-based pcr to provide quantitative and qualitative detection of nucleic acid sequences. Customer reported they smelled something burnt from an un-known source and called the house electrician. When he arrived a few minutes later there was lots of smoke coming out of the m2000rt instrument and shortly after they saw flames as well from the heater block area while it was running. They used a fire extinguisher and killed the flames. The customer unplugged the instrument from the power socket and the smoke formation stopped. No one was injured and there was no visible damage external to the m2000rt instrument. Engineer was dispatched. An elevated complaint investigation has been opened to address this issue. According to the current version of adverse event reporting procedure, am23-01-002, this issue meets the criteria for an mdr "always reportable" event for visible smoke and fire. No patient was involved, the observation was made by a user who confirmed there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
[107110272]
A new m2000rt instrument system has been installed at the customer site. Investigation into this event is still underway. To-date, the following has been included within the investigation: a search of our complaint management system for the m2000rt instrument system over the past two years was completed and showed that only the complaint ticket associated with this mdr was related to evidence of smoke/fire observed external to the m2000rt instrument system. Further complaint history review dating back to 2006 was completed and no additional complaints have been received related to external smoke/fire associated with the m2000rt instrument system. A review of internal nonconformance and capa investigation records over the past two years indicates there were no records for smoke or fire observed external to the m2000rt instrument system. Further review dating back to 2006 was completed and there have been no non-conformance or capa records related to external smoke/fire associated with the m2000rt instrument. A review of the service history for the impacted instrument serial number identified no other tickets that were related to evidence of smoke or fire on this instrument. The review of all tickets did not indicate a systemic m2000rt instrument system performance issue. A review of the m2000rt operations manual verified that the m2000rt instrument system is certified to u. S, canadian, and european safety standards. A timeline of events occurring on (b)(6) 2018 with the m2000rt instrument (sn (b)(4)) was compiled based on a combination of the instrument log file analysis and activity comments associated with complaint (b)(4). The timeline indicates that the instrument performed an expected 59? C soak for reverse transcriptase and then started to ramp up to the 95? C set point for the first thermal cycle. The block never reached a 95? C set point. The peak temperature of 79. 1? C occurred approximately seven minutes before the power cord was pulled on the instrument. Thermo fisher and abbott molecular continue to investigate. The preliminary investigation results indicate that the m2000rt instrument circuitry demonstrated compliance with (b)(4). Therefore, no corrective actions are planned at this time, pending further investigation.
Patient Sequence No: 1, Text Type: N, H10
[109119116]
Correction to describe event or problem for order of events at customer site - the customer disconnected the m2000rt instrument system power cord from the power outlet and noted the smoke stopped. The fire extinguisher in the lab was used to put out any remaining smoke and flame. Summary of complaint investigation: a new m2000rt instrument system has been installed at the customer site. Investigation into this event has been completed. Investigation into this complaint included complaint history review, quality data review, service history review, returned instrument evaluation and engineering controls evaluation. A search of our complaint management system for the m2000rt instrument system over the past two years was completed and showed that only the complaint ticket associated with this mdr was related to evidence of smoke/fire observed external to the m2000rt instrument system. Further complaint history review dating back to 2006 was completed and no additional complaints have been received related to external smoke/fire associated with the m2000rt instrument system. Thermofisher additionally reported no history of a similar complaint of their instruments (which share similar components with the m2000rt instrument) from 2009 to 2018. A review of internal nonconformance and capa investigation records over the past two years indicates there were no records for smoke or fire observed external to the m2000rt instrument system. Further review dating back to 2006 was completed and there have been no non-conformance or capa records related to external smoke/fire associated with the m2000rt instrument. A review of the service history for the impacted instrument serial number identified no other tickets that were related to evidence of smoke or fire on this instrument. The review of all tickets did not indicate a systemic m2000rt instrument system performance issue. A review of the m2000rt operations manual verified that the m2000rt instrument system is certified to u. S, canadian, and european safety standards. A timeline of events occurring on (b)(6) 2018 with the m2000rt instrument (sn (b)(4)) was compiled based on a combination of the instrument log file analysis and activity comments associated with complaint ticket (b)(4). The timeline indicates that the instrument performed an expected 59? C soak for reverse transcriptase and then started to ramp up to the 95? C set point for the first thermal cycle. The block never reached a 95? C set point. The peak temperature of 79. 1? C occurred approximately seven minutes before the power cord was pulled on the instrument. The supplier, thermofisher, failure analysis investigation concluded the heatsink fan (contained within the block drive component of the m2000rt) as the most likely source of the fire. The circuitry function was tested by thermofisher and verified to be intact and failing safe. Engineering evaluation of the circuitry demonstrated compliance with iec/en (b)(4). Engineering controls evaluation: the engineering controls for the prevention of the spread of fire outside of the instrument identified as part of the design of the m2000rt instrument system meet the requirements of iec/en (b)(4). Compliance with the iec/en (b)(4) requirement is demonstrated by utilizing limited energy circuits, required flammability ratings for non-metallic materials and enclosures as part of the design of the instrument. The m2000rt instrument has the following engineering controls in place: the heatsink fan control circuit meets the iec/en (b)(4) requirements for a limited energy circuit. The non-metallic heatsink fan, front enclosure and front door of the m2000rt instrument have highest flammability rating of v-0, indicating the highest protection against the spread of fire. The metal and non-metallic components of the m2000rt instrument system's enclosure meet the requirements defined in clause 9 of iec/en (b)(4) for the prevention of the spread of fire outside of the instrument. The customer reported when they disconnected the m2000rt instrument system power cord from the power outlet, the smoke stopped. This is evidence that the flammability engineering controls defined above operated as designed. Additionally, evaluation of the circuitry and engineering controls in the m2000rt instrument system indicates the fire would have self-extinguished and prevented spread of fire outside of the instrument as designed if customer intervention had not occurred. Based on the results of the investigation, it is concluded that the reported event met the requirements of m2000 product design requirements and, therefore, clause 9 of safety standard iec/en (b)(4). No product deficiency was identified for the heatsink fan, m2000rt instrument, serial (b)(4), or the m2000rt instrument systems, list number 09k15-01. Therefore, no corrective actions are planned.
Patient Sequence No: 1, Text Type: N, H10
[109119117]
The abbott m2000 realtime system is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the abbott m2000sp and abbott m2000rt instruments. The abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The abbott m2000rt is an automated system for performing fluorescence-based pcr to provide quantitative and qualitative detection of nucleic acid sequences. Customer reported they smelled something burnt from an un-known source and called the house electrician. When he arrived a few minutes later there was lots of smoke coming out of the m2000rt instrument and shortly after they saw flames as well from the heater block area while it was running. The customer disconnected the m2000rt instrument system power cord from the power outlet and noted the smoke stopped. The fire extinguisher in the lab was used to put out any remaining smoke and flame. No one was injured and there was no visible damage external to the m2000rt instrument. Engineer was dispatched. An elevated complaint investigation has been opened to address this issue. According to the current version of adverse event reporting procedure, am23-01-002, this issue meets the criteria for an mdr "always reportable" event for visible smoke and fire. No patient was involved, the observation was made by a user who confirmed there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
[114839782]
On june 26th, the following information was included or updated within the abbott molecular quality system in response to fda questions on supplemental mdrs for 3005248192-2018-00003. Therefore supplemental report is being provided to update the manufacturer's narrative to include those additional elements. As part of instrument and spare parts release testing prior to distribution, thermofisher (instrument manufacturer), performs testing of each block drive assembly, of which the fan assembly is a component. The testing cycles the assembly to simulate a customer run which includes ramping the block temperature up and down between 35? C and 95? C. Thermofisher also provided evidence that the heatsink fan manufacturer has not experienced any cases of fire on the part in question.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2018-00003 |
| MDR Report Key | 7361667 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-22 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2018-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000RT INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | OOI |
| Date Received | 2018-03-22 |
| Catalog Number | 09K15-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Brand Name | ABBOTT M2000RT INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2018-03-22 |
| Returned To Mfg | 2018-03-21 |
| Catalog Number | 09K15-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-22 |