MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-20 for ABBOTT M2000SP INSTRUMENT 09K14-02 manufactured by Abbott Molecular, Inc..
[136641281]
An elevated complaint investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[136641282]
The customer reported an incident that a lab technician was disposing the red hazardous bag from the m2000sp instrument to their waste bag for hazardous goods to be sent for incineration, and a tip ripped through the red bag and her gloves which cut her finger. The customer stated that the lab technician was taking out the solid waste bag and transferring it to another bag. The technician pushed down on the bag, which caused the puncture of the tip through the bag and the technician's glove. They were testing (b)(6) samples. The customer reported it was a superficial scratch on their finger, and there was evidence of blood. The customer completed an internal investigation of their process for waste disposal. The customer believed it was an internal handling issue rather than an incident caused by an abbott product deficiency. The customer has since changed their internal practice for solid waste disposal. The customer blames internal waste handling and not abbott for this reported incident. The lab technician went to occupational health, and testing and precautions were completed. The customer stated that the affected user received (b)(6) prophylaxis, hbv booster injection, and baseline blood was taken. The user will be tested in a month for blood borne viruses. 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 united kingdom 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 | 3005248192-2019-00003 |
| MDR Report Key | 8354169 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-20 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2011-07-13 |
| Date Added to Maude | 2019-02-20 |
| 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 M2000SP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2019-02-20 |
| Catalog Number | 09K14-02 |
| Device Availability | Y |
| 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. Required No Informationntervention | 2019-02-20 |