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 2017-06-01 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[76536110]
A customer in (b)(6) notified biom? Rieux of a misidentification associated with the vitek? 2 ast-n233 test kit (reference (b)(4) involving an eeq cclin ouest strain. The customer reported the vitek? 2 ast-n233 card results were klebsiella oxytoca; however, the expected result was acinetobacter baumanii. The strain was tested twice on the vitek? 2 with the same results. In addition, the customer indicated testing with api? 20e and the result was acinetobacter baumanii. The customer indicated the discrepancy did not involve a patient or healthcare provider as it was an eeq strain that was tested. Therefore, there was no adverse events, negative impact or delays related to this discrepancy. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00171 |
| MDR Report Key | 6605326 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-01 |
| Date of Report | 2017-08-04 |
| Date Mfgr Received | 2017-07-11 |
| Device Manufacturer Date | 2017-02-05 |
| Date Added to Maude | 2017-06-01 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. 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 CARD |
| Product Code | JTO |
| Date Received | 2017-06-01 |
| Catalog Number | 21341 |
| Lot Number | 2410071103 |
| ID Number | 03573026131913 |
| Device Expiration Date | 2018-02-05 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |