MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for VITEK? 2 AST-N288 TEST KIT 414972 manufactured by Biomerieux, Inc.
[72786250]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 ast-n288 test kit. The customer reported the results per vitek? 2 ast-n288 for proteus mirabilis were intermediate (i) for imipenem; however, the results using another method were susceptible (s). There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00115 |
| MDR Report Key | 6481611 |
| Date Received | 2017-04-11 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-04-11 |
| 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 | 0 |
| Brand Name | VITEK? 2 AST-N288 TEST KIT |
| Generic Name | VITEK? 2 AST-N288 TEST KIT |
| Product Code | JTT |
| Date Received | 2017-04-11 |
| Catalog Number | 414972 |
| Lot Number | 7080178403 |
| Device Expiration Date | 2018-05-23 |
| 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 | 2017-04-11 |