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 2017-12-15 for VITEK? 2 AST-YS08 TEST KIT 420739 manufactured by Biomerieux Inc..
[95908825]
A customer in (b)(6) notified biom? Rieux of a false susceptible result while testing an external quality control (eqc) (ref. 2017-3) from biological prospective for antifungal susceptibility using biomerieux vitek? 2 ast-ys08. The customer tested the eqc sample for identification using vitek? 2 ast-ys08 card and candida norvegensis was identified. The customer reported that they had tested and subcultured the strain and obtained:? Fluorocytosine: mic value of 4 indicating the fungus to be susceptible to fluorocytosine whereas the expected result was resistant. ? Fluconazole: mic value of 16 indicating intermediate whereas the expected result was resistant. The medium of culture was sabouraud gentamicine chloramph? Nicol 2. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient associated with this survey isolate. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00454 |
| MDR Report Key | 7120367 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-15 |
| Date of Report | 2018-05-11 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-12-15 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 2017-12-15 |
| Catalog Number | 420739 |
| Lot Number | 2880150203 |
| Device Expiration Date | 2017-04-25 |
| 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 | 2017-12-15 |