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 2018-09-18 for VITEK?2 GN ID CARD 21341 manufactured by Biomerieux, Inc..
[120737422]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 gn id card (reference (b)(4)). The customer reported salmonella enterica subsp. Enterica servor diarizonae was identified with gn cards. The customer considered this was not salmonella according to antiserum and other testing was performed which resulted in citrobacter freundii. The other tests were performed with tsi media and sim media, but not with api? , vitek ms or 16s. The correct result of c. Freundii was reported to the physician. There was no delay in reporting results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00372 |
| MDR Report Key | 7885702 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-18 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2018-09-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GN ID CARD |
| Generic Name | VITEK?2 GN ID CARD |
| Product Code | LQM |
| Date Received | 2018-09-18 |
| Catalog Number | 21341 |
| Lot Number | 2410495203 |
| Device Expiration Date | 2019-04-05 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-18 |