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 2016-05-11 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[45031586]
A customer in italy notified biomerieux of a discrepant result associated with vitek 2 ast-ys07 test kit. The customer reported the vitek 2 ast-ys07 card found fluconazole 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
[48995525]
A customer reported false susceptible results for voriconazole (vrc) and fluconazole (flu) on vitek 2 cards (ast-ys07), for a strain of candida albicans, while the customer reference method (sensititre), gave a resistant result. Customer results: strain was subcultured on cba and sda media. Ast-ys07 - lot#- 287346720tested on vitek 2 v7. 01: voriconazole (vrc) minimum inhibitory concentration (mic): <=0. 125mg/l
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00053 |
| MDR Report Key | 5646329 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-26 |
| Date Mfgr Received | 2016-04-26 |
| Date Added to Maude | 2016-05-11 |
| 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 | MR. JONATHAN NONNEMACHER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196203396 |
| 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 AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 TEST KIT |
| Product Code | NGZ |
| Date Received | 2016-05-11 |
| Catalog Number | 414967 |
| Lot Number | 287346720 |
| Device Expiration Date | 2016-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-05-11 |