MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-05-08 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.
[107585136]
During literature review performed by biom? Rieux, a misidentification result was noted in the article "candida auris: a systemic review and meta-analysis of current updates on an emerging multidrug-resistant pathogen," authored by john osei sekyere. According to the article, vitek? 2 yst id test kit (ref 21343), misidentified candida auris as candida haemulonii and candida duobushaemulonii. It should be noted that c. Auris was not a claimed species until vitek 2 version 8. 01 for yst cards. The article also cites articles regarding vitek 2 antifungal testing despite the fact that c. Auris is not claimed on vitek 2 antifungal cards. There is no indication from the article that the discrepant result led to any 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 | 1950204-2018-00177 |
| MDR Report Key | 7494115 |
| Report Source | LITERATURE |
| Date Received | 2018-05-08 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-06-14 |
| Date Added to Maude | 2018-05-08 |
| 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 | 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 | ST. 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 YEAST (YST) IDENTIFICATION (ID) TEST KIT |
| Generic Name | VITEK? 2 YST ID TEST KIT |
| Product Code | JXB |
| Date Received | 2018-05-08 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-08 |