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 2015-12-28 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[34474215]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[34474216]
A customer in (b)(6) contacted biomerieux to report a discrepant (b)(6) organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit. Corynebacterium ulcerans was misidentified as corynebacterium minutissinum. Upon retesting, the correct result of corynebacterium ulcerans was obtained. There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to any patient's state of health. No patient was directly associated with the abp survey result. Culture submittals have been requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[38095438]
Biom? Rieux investigation was conducted. Investigational testing included: - vitek? 2 anc id cards (customer lot expired, so two random lots were tested) to check the customer result, - vitek? Ms, - api? Coryne strip. Results: - vitek? 2 anc id: excellent identification to corynebacterium ulcerans, for both lots tested. - vitek? Ms: excellent identification to the species corynebacterium ulcerans. - api? Coryne strip: doubtful profile with a possibility of corynebacterium minutissimum. The investigation did not reproduce the vitek? 2 anc id misidentification to the species corynebacterium minutissimum obtained by the customer. The investigation also determined the customer was sub-culturing to a non-recommended media. The customer retested with recommended media (cba) and obtained the correct result. The misidentification appears to be related to the use of non-recommended media by the customer. Based on the results of the investigation, the vitek? 2 anc id is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2015-00130 |
| MDR Report Key | 5329407 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-28 |
| Date of Report | 2015-12-02 |
| Date Mfgr Received | 2015-12-02 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2015-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2015-12-28 |
| Catalog Number | 21347 |
| Lot Number | 244331010 |
| Device Expiration Date | 2016-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-12-28 |