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 2018-08-10 for VITEK?2 AST-YS08 TEST KIT 420739 manufactured by Biomerieux, Inc.
[117287721]
A customer in france notified biomerieux of discrepant results associated with vitek 2 ast-ys08 test kit (reference (b)(4) the customer reported the impacted eeq strain is candida glabrata species and the discrepant result regarding the mic value for voriconazole. While testing this strain on the impacted lot of vitek2 ast-ys08 card, a mic value= 1mg/l, susceptible result instead of resistant as expected for this strain by the survey was obtained. The customer decided to repeat testing on vitek2 ast-ys08 and this time obtained mic value greater than 4mg/l and 8mg/l, resistant. The customer used a can media, the incubation time was 24h, the purity was checked and conformed also the mac farland. The saline solution, quality control and last maintenance were conformed. The internal quality control result conformed and maintenance was complete. The results of this survey for this strain are as follows: (b)(6) of the laboratories obtained a resistant result as expected. No patient outcomes were reported due to the referenced issue as it occurred during an external quality control survey. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00284 |
| MDR Report Key | 7772832 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-10 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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-YS08 TEST KIT |
| Generic Name | VITEK?2 AST-YS08 TEST KIT |
| Product Code | NGZ |
| Date Received | 2018-08-10 |
| Catalog Number | 420739 |
| Lot Number | 2880454103 |
| Device Expiration Date | 2019-02-23 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-10 |