MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[36273081]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[36273082]
A customer in (b)(6) contacted biomerieux to report a discrepant organism identification in association with the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit. Propionibacterium species was misidentified as atopodium vaginae. Upon obtaining atopodium vaginae result for a male patient, an alternate method of testing (crystal) was employed. The result of propionibacterium agnes (or granulosum) 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 the patient's state of health. 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
| Report Number | 1950204-2016-00130 |
| MDR Report Key | 5360328 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-29 |
| Date Mfgr Received | 2015-12-29 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2016-01-12 |
| 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 | 0 |
| Brand Name | VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2016-01-12 |
| Catalog Number | 21347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-01-12 |