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 2017-01-26 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[65914195]
A customer from (b)(6) reported to biom? Rieux a false susceptible result for a candida glabrata external quality control sample, in association with the vitek? 2 ast-ys07 test kit. The customer twice tested the strain with ast-ys07 and obtained a result of fluconazole susceptible (mic=2) when the expected result was fluconazole resistant (mic=16-32). The strain was cultured on cos (columbia + sheep blood) media for 24 hours at 37? C. The customer reported the incorrect result was not reported to a physician and did not impact a patient results or treatment. The test reports were requested from the customer. A biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00033 |
| MDR Report Key | 6281000 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-26 |
| Date of Report | 2017-07-11 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2015-10-23 |
| Date Added to Maude | 2017-01-26 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 CARD |
| Product Code | NGZ |
| Date Received | 2017-01-26 |
| Catalog Number | 414967 |
| Lot Number | 287378322 |
| Device Expiration Date | 2017-04-23 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-26 |