MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-05-08 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.
[107721753]
During literature review performed by biom? Rieux, misidentification results were noted in a study jointly collaborated by (b)(6). The results were summarized in the article, "clinically relevant yeast species identified by sequencing the internal transcribed spacer region of r-rna gene and vitek 2 compact (yst card) commercial identification system: experience in a tertiary care hospital in assam, northeast india," authored by reema nath, reeta bora, biswajyoti borkakoty, lahari saikia, and pratap parida. According to the article, vitek? 2 yst id test kit (ref 21343), misidentified unclaimed species as follows: cutaneotrichosporon debeurmannianum was misidentified as cryptococcus laurentii, candida metapsilosis was misidentified as candida parapsilosis, candida mesorugosa was misidentified as candida rugosa, candida akabanensis was misidentified as candida rugosa. There is no indication from the article that the discrepant results 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 | 1950204-2018-00179 |
| MDR Report Key | 7496443 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-05-08 |
| Date of Report | 2018-08-06 |
| Date Mfgr Received | 2018-07-12 |
| 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 | MRS. CANDACE MARTIN |
| 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 | 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 |