MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION CARD (ANC) TEST KIT 21347 manufactured by Biomerieux, Inc.
[68610442]
A customer in (b)(6) notified biom? Rieux of a discrepant result associated with vitek? 2 anaerobic and corynebacteria identification card (anc) test kit. As part of ctcb (centre toulousain pour le contr? Le de qualit? En biologie) external control 1641, the customer reported the vitek? 2 anc card identified a strain as turicella otitidis instead of rhodococcus equi. The customer obtained results of turicella otitidis at 99%, however, the expected result is rhodococcus equi. Rhodococcus equi is not part of the database for the anc cards. There is a limitation statement in the product information manual that states: "newly described or rare species may not be included in the anc database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification". However, the vitek 2 obtained an incorrect identification of myroides at turicella otitidis at 99%. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75250858]
An internal biom? Rieux investigation was performed with results as follows: previous reference testing has identified this isolate as rhodococcus equi. Testing included vitek? Anc cards, one card from two different lots. On vitek? 2, anc card gave with both lots, an unidentified organism. In-house, the misidentification to the species turicella otidis obtained by the customer with discrepant test results : (ure), was not reproduced. Note: rhodococcus equi is out of the gram negative (gn) card knowledge base. There is a limitation on vitek? 2 for species not claimed in the knowledge base: testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00074 |
| MDR Report Key | 6367661 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2017-03-01 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 CARD (ANC) TEST KIT |
| Generic Name | VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION CARD (ANC) TEST KIT |
| Product Code | JSP |
| Date Received | 2017-03-01 |
| Catalog Number | 21347 |
| Lot Number | 244390210 |
| Device Expiration Date | 2017-08-20 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |