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 2016-05-16 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biom?rieux, Inc..
[45256780]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[45256781]
A customer in (b)(6) notified biomerieux of a discrepant result associated with the vitek 2 ast-ys07 test kit. The customer reported the vitek 2 ast-ys07 card found voriconazole to be susceptible for a patient strain while their reference method, sensititre, gave them resistant. The patient strain has been requested from the customer. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2016-00056 |
| MDR Report Key | 5657736 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-16 |
| Date of Report | 2016-05-12 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2014-12-11 |
| Date Added to Maude | 2016-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 TEST KIT |
| Product Code | NGZ |
| Date Received | 2016-05-16 |
| Catalog Number | 414967 |
| Lot Number | 287346720 |
| Device Expiration Date | 2016-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-16 |