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 2018-08-21 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux, Inc..
[118239145]
A poster presented at the ammi-cacmid meeting (canadian microbiology convention) contained information on the misidentifications of candida auris isolates in association with the vitek? 2 yst test kit. Biom? Rieux contacted the author for more information. It was reported that c. Auris was misidentified as c. Duobushaemulonii and c. Lusitaniae/c. Duobushaemulonii. The author who performed the testing, sent their survey results to the (b)(6), which they had obtained using vitek 2 version 7. 01. The author stated no c. Auris isolates were identified by vitek 2 v7. 01 in their lab. At the same time, their lab was upgraded to vitek 2 v8. 01. Testing was then repeated with the new version 8. 01. There was a miscommunication with the (b)(6) about testing with the two versions upon the poster abstract review. (b)(6). There was no patient involvement as testing was performed on survey samples. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00291 |
| MDR Report Key | 7802216 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-21 |
| Date of Report | 2018-10-30 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-08-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| 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 YST TEST KIT |
| Generic Name | VITEK? 2 YST TEST KIT |
| Product Code | JXB |
| Date Received | 2018-08-21 |
| Catalog Number | 21343 |
| 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 | 2018-08-21 |