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 2016-09-14 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[54689046]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[54689047]
A customer in (b)(6) reported the occurrence of a false susceptible voriconazole result for candida albicans in association with the vitek 2 ast-ys07 test kit. Etest voriconazole provided a resistant result. Repeat testing obtained the same respective results. The customer reports a delay in reporting due to the additional testing performed. The patient was treated with a different antimycoticum. The customer sent the patient strain to a reference laboratory. The reference laboratory obtained results of resistant to voriconazole (test method unknown), confirming the vitek 2 ast-ys07 result to be discrepant. There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to the patient's state of health. Internal biomerieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2016-00123 |
| MDR Report Key | 5949566 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-14 |
| Date of Report | 2016-08-15 |
| Date Mfgr Received | 2016-08-15 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2016-09-14 |
| 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 AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 TEST KIT |
| Product Code | NGZ |
| Date Received | 2016-09-14 |
| Catalog Number | 414967 |
| Lot Number | 287394320 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-14 |