MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-08-05 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[51348354]
A customer notified biomerieux of a mis-identification when using the vitek 2 anc test kit. An atcc quality control sample of clostridium septicum (atcc 12464) was run and gave the results of dglu+, bman+, mte+, and ops-. The expected results are dglu-, bman-, mte-, and ops+. When specifically asked the customer noted no injury or death happened as a result of this incident. An investigation has been initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
[58088667]
An investigation into a product issue while using the vitek? Anc test kit was performed. The customer reported discrepant results with a qc sample. Testing was performed on 4 anc cards (customer lot twice: 244379420 and random lot twice: 244366910 on cba in an anaerobic atmosphere) on each strain tested, both the customer and an internal reference strain. The customer strain was tested. The discrepant results were duplicated. When the internal reference strain was tested, the results were as expected. Qc was conforming in-house with all lots tested whatever the media used for the internal reference strain. Therefore, the most likely cause of this event is a degraded strain from the customer. Anc cards performed as intended and no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00085 |
| MDR Report Key | 5851691 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-04 |
| Date Mfgr Received | 2016-07-04 |
| Date Added to Maude | 2016-08-05 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST KIT |
| Product Code | JSP |
| Date Received | 2016-08-05 |
| Catalog Number | 21347 |
| Lot Number | 244379420 |
| Device Expiration Date | 2017-05-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-05 |