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 2018-09-14 for VITEK? 2 AST-YS08 TEST KIT 420739 manufactured by Biomerieux, Inc..
[121565023]
A customer in (b)(6) notified biom? Rieux of false susceptible fluconazole results for eeq biologie prospective 2018-2a, candida glabrata, when testing with the vitek? 2 ast-ys08 test kit. The customer obtained a susceptible result, mic=2. The expected result for this survey strain is resistant. The customer retested the strain and obtained the same susceptible result, mic = 2. There is a limitation for flu02n on the ys08 card against c. Glabrata that states: perform an alternative method of testing prior to reporting of results. However, this customer is running software version 7. 01. There was no default bioart rule in this version for the candida glabrata limitation. A mar has been issued instructing customers to add a bioart rule for this limitation. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00364 |
| MDR Report Key | 7878611 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-14 |
| Date of Report | 2018-11-14 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2018-09-14 |
| 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. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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-YS08 TEST KIT |
| Generic Name | VITEK? 2 AST-YS08 TEST KIT |
| Product Code | NGZ |
| Date Received | 2018-09-14 |
| Catalog Number | 420739 |
| Lot Number | 2880297203 |
| Device Expiration Date | 2018-09-19 |
| 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 | 2018-09-14 |