MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-22 for VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux, Inc.
[78381500]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[78381501]
A customer from the united states notified biom? Rieux of a misidentification associated with the vitek? 2 gn test kit. The customer reported the vitek? 2 gn id card identified the organism as klebsiella oxytoca, but the spot indole was negative. In addition, the api? Result was klebsiella pneumonia. The customer indicated the setup process had not changed, there were no contamination issues, and they were using pure cultures. The customer reported having no issues with any other organism identifications. There is no information to support negative patient impact or serious adverse events occurred as a result of this discrepancy. Isolate submittals were requested. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00197 |
| MDR Report Key | 6659582 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-22 |
| Date of Report | 2017-08-10 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2017-06-22 |
| 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 | HAZELWOOD 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 GRAM-NEGATIVE IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | JTO |
| Date Received | 2017-06-22 |
| Catalog Number | 21341 |
| Lot Number | 2410128403 |
| Device Expiration Date | 2018-04-03 |
| 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 | 2017-06-22 |