MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-28 for ABBOTT M2000SP INSTRUMENT 09K14-02 manufactured by Abbott Molecular, Inc..
[118529466]
An elevated complaint investigation will be performed. H4 will be provided with the follow up report.
Patient Sequence No: 1, Text Type: N, H10
[118529467]
The abbott m2000 system is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the abbott m2000sp and the 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. The customer states that their master mix addition run for hiv-1 routine ended normally. The customer tried to lift the amplification reagent packs from the assay reagent holder on the output deck of the m2000sp instrument to discard them, but the packs didn't come out easily, so the customer applied more force to do so. At one time while lifting, the customer couldn? T take the amplification pack, and her hand crashed with the robotic manipulator arm, resulting in tearing of the glove and a cut on the knuckles with blood. After that, the customer tried to clean the blood from the arm, but she cut her index finger (while using gloves), reporting the edge of the arm is sharp. The customer washed her injuries for 30 minutes with water and soap. Customer stated she went to the physician after the accident. She was tested for hiv-1, hcv and hbv; results were negative. She was vaccinated against tetanus and is under antiretroviral treatment for 1 month. No patient was involved, injury was sustained by an abbott m2000sp instrument user. This incident is being reported to fda because the incident occurred in colombia using the m2000sp instrument, list number 09k14-02, which is also approved for use in the united states.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00010 |
| MDR Report Key | 7825190 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-28 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-08-31 |
| Device Manufacturer Date | 2011-07-06 |
| Date Added to Maude | 2018-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 M2000SP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | OOI |
| Date Received | 2018-08-28 |
| Catalog Number | 09K14-02 |
| 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 M2000SP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2018-08-28 |
| Returned To Mfg | 2018-09-18 |
| Catalog Number | 09K14-02 |
| 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 | 1. Other | 2018-08-28 |