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 2018-02-07 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc..
[99328307]
A customer in (b)(6) notified biom? Rieux of obtaining false susceptible fluconazole results for an external quality assessment candida norvengensis strain (biologie prospective 2017-3) when testing with vitek? 2 ast-ys07 test kit (reference 414967). The customer had tested the eqa sample for identification, and candida norvegensis was identified. The customer reported that they had tested a sub-cultured strain of the eqa sample with vitek 2 obtaining mic=8 (s) on initial testing and mic=16 (i) on repeat testing. The minimal inhibitory concentration (mic) value of 8 indicated the fungus to be susceptible to fluconazole; whereas, the expected result was resistant. The medium of culture was chromid candida agar. 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. There was no patient associated with this quality strain. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00064 |
| MDR Report Key | 7247873 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-07 |
| Date of Report | 2018-05-10 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2018-02-07 |
| 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 | 2018-02-07 |
| Catalog Number | 414967 |
| Lot Number | 2870024203 |
| Device Expiration Date | 2017-12-20 |
| 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 | 2018-02-07 |