MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-01 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.
[110052388]
A customer from the united states notified biom? Rieux of a yeast misidentification for a cap survey sample (survey f1-a 2018) in association with the vitek? 2 yst test kit (lot # 2430224403). Vitek 2 obtained a result of candida parapsilosis as a single-choice organism on initial testing. The expected result for this specific cap survey sample, specimen f1-01, included candida tropicalis or candida species, not albicans. After receiving the survey results, the customer repeated testing and obtained an identification of candida tropicalis as expected. 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 | 1950204-2018-00207 |
| MDR Report Key | 7561021 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-01 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2018-06-01 |
| 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 | 2018-06-01 |
| Catalog Number | 21343 |
| Lot Number | 2430224403 |
| Device Expiration Date | 2018-07-08 |
| 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 | 2018-06-01 |