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 2017-03-29 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[71474478]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 gn test kit (reference 21341) related to misidentification of an organism. The customer reported results from a urine isolate. The organism grew from a pure urine culture at 35 degrees in non-co2 incubator. It was a non-lactose fermenting organism and the vitek? Id card identified the organism as salmonella both times. The serology for salmonella was negative and the customer sent the organism to their reference laboratory which identified the organism as e. Coli. The "maldit" of identification was also e. Coli and simple tests showed the following reactions: indole +/-, lactose negative, tsi= a/a no h2s. 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. There was a delay in the final report until confirmation identification was received from bccdc. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00100 |
| MDR Report Key | 6441987 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-29 |
| Date of Report | 2017-07-26 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-03-29 |
| 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 | 2017-03-29 |
| Catalog Number | 21341 |
| Lot Number | 241396710 |
| Device Expiration Date | 2017-10-24 |
| 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 | 2017-03-29 |