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 2018-01-24 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc..
[98292522]
A customer in (b)(6) notified biom? Rieux of a false susceptible result when testing an external quality assessment (eqa) candida guilliermondii strain from labquality (eqa round 4 2017 - specimen s001) for antifungal susceptibility with vitek? 2 ast-ys07 (ref 414967). The customer had tested the eqa sample for identification and obtained candida guilliermondii as expected. When testing with the ast-ys07 card, they had obtained a minimal inhibitory concentration (mic) value of 2, indicating the fungus to be susceptible to fluconazole. The expected result was resistant. Labquality identified the strain as resistant with a mic value at 256 and another at 8 with e-test. The labquality (eqa round 4 2017) report defines specimen s001 as follows: "a yeast strain isolated from blood culture from a liver-transplant patient". There is no indication or report from the customer to biom? Rieux that the discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00040 |
| MDR Report Key | 7215235 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-24 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2018-01-24 |
| 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 | 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 | 2018-01-24 |
| Catalog Number | 414967 |
| Lot Number | 2870157203 |
| Device Expiration Date | 2018-05-02 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-24 |