MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-15 for ABBOTT M2000RT INSTRUMENT 09K15-01 manufactured by Abbott Molecular, Inc..
[103154974]
An investigation will be initiated and a follow up report will be sent after it is concluded.
Patient Sequence No: 1, Text Type: N, H10
[103154975]
Customer witnessed an electrical spark when she dropped a paper clip into a hole in the top of the uninterruptible power supply (ups) used with their m2000rt instrument. Customer stated that she was talking to molecular application specialist (mas) and placing a partially straightened paper clip near an open hole on top of the ups. Customer stated she accidentally dropped the straight part of the paper clip into the hole causing the spark. Customer did confirm that she dropped the paper clip into the hole on top where a stopper or plug should have been. Mas asked customer about when the stopper or plug was removed, but customer cannot recall when or how that stopper was removed. Customer stated that the paper clip falling onto this section caused an electrical spark and then a small amount of smoke from the spark. Customer confirmed that she was not injured or shocked during the incident. Customer confirmed that no fire started from the electrical spark. Customer stated that she could smell the smoke from the electrical spark. Mas instructed the customer to immediately power everything down and unplug the ups and everything plugged into the ups. Mas also instructed customer to plug the instrument and scc into the wall and leave the ups powered off. Review of complaint description, pictures provided and labeling indicate this event was likely caused by use error. However, 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. 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
| Report Number | 3005248192-2018-00002 |
| MDR Report Key | 7343830 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-15 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-03-15 |
| 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 , JJH |
| Product Code | JJH |
| Date Received | 2018-03-15 |
| Returned To Mfg | 2018-03-29 |
| 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 | 2018-03-15 |