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 2017-03-08 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[69560543]
A customer in france notified biom? Rieux of discrepant results associated with vitek? 2 gn test kit ((b)(4)) related to misidentification of pseudomonas aeruginosa and brevundimonas diminuta instead of rhodococcus equi. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75652759]
A customer in (b)(6) notified biom? Rieux of a misidentified rhodococcus equi as pseudomonas aeruginosa and brevundimonas diminuta for an eeq survey sample in association with vitek? 2 gn test kit (udi (b)(4)). An investigation was performed. Previous reference testing has identified this isolate as rhodococcus equi. Rhodococcus equi is out of the gn card knowledge base. There is a limitation on vitek? 2 for species not claimed in the knowledge base. Newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00084 |
| MDR Report Key | 6388983 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-08 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-03-08 |
| 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 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST KIT |
| Product Code | JTO |
| Date Received | 2017-03-08 |
| Model Number | 21341 |
| Lot Number | 241389540 |
| ID Number | 03573026131913 |
| Device Expiration Date | 2017-08-13 |
| 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 | 2017-03-08 |