MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-02-13 for ABBOTT M2000SP INSTRUMENT 09K14-02 manufactured by Abbott Molecular, Inc..
[67318577]
Investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[67318578]
The abbott m2000 system is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is composed of the m2000rt and the m2000sp instruments. The m2000sp is intended for automated sample preparation and nucleic acid extraction prior to testing. Customer reported one of the tubing connectors from the top of the liquid waste container was broken. The field service engineer (fse) from the distributor went on site to assess the situation. On site, the fse confirmed that the white male connection was broken. Fse removed the liquid waste container, emptied the waste, rinsed with water, then cleaned with 2% bleach, and then re-rinsed with water. Fse then changed the waste tubing of the white male connector. To change the waste tubing, the fse tried cutting the tubing with a knife to change the connector. The knife slipped and the fse cut herself in one finger. She was wearing gloves when this occurred, but a slight scrape was created on one of her fingers. The fse contacted two physicians. One of them did not recommend starting a treatment since the cut was very lightly done; the other one recommend starting an antiretroviral (arv) therapy as a precaution. Fse confirmed that she started taking the arv therapy. Although the field service engineer sustained this injury when utilizing a non-abbott implement (knife) while cutting tubing, arv therapy has been started as a result of the potentially biohazardous exposure associated with the use of the m2000sp instrument.
Patient Sequence No: 1, Text Type: D, B5
[69223204]
Summary of complaint investigation for mdr 3005248192-2017-00001 follow-up report 1: investigation into this complaint included an evaluation of the quality data review and complaint history review. Quality data review: the m2000sp e-series service manual 50-608125/r4 - october 2012 contains explicit warnings regarding the use of sharp tools and overall safety with instructions to wear appropriate personal protective equipment such as gloves, lab coat and protective eyewear. In addition, there are no instructions to use a knife to remove tubing from any connections. The m2000sp operations manual 200681-109 - march 2016 provides adequate instruction for servicing the liquid waste container and to wear appropriate personal protective equipment such as gloves, lab coat and protective eyewear. Customer data was reviewed in the form of one photograph, which showed the extent of the scrape on the fse's left index finger. Complaint history review: a two year complaint history review verified that this is the only complaint involving an fse injury from a knife or sharp tool. Product deficiency decision: based on the investigation results, no product deficiency has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2017-00001 |
| MDR Report Key | 6327579 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-02-13 |
| 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 | MRS. SARAH PARKER |
| Manufacturer Street | 1300 EAST TOUHY AVENUE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617355 |
| 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 | 2017-02-13 |
| Catalog Number | 09K14-02 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-13 |