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.
[110591372]
A customer from the united states notified biom? Rieux of a yeast misidentification for a cap survey sample (survey (b)(4) 2018) in association with the vitek? 2 yst test kit (lot # 2430224403). The expected result for this specific cap survey sample, specimen (b)(4), included candida guilliermondii, candida famata/guilliermondii or candida species, not albicans. With initial testing on (b)(6) 2018, vitek 2 obtained a low discrimination result between candida famata / candida guilliermondii as expected. The customer repeated testing on (b)(6) 2018 and obtained a result of candida famata as a single-choice organism. 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 | 1950204-2018-00208 |
MDR Report Key | 7562241 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2018-06-01 |
Date of Report | 2018-07-23 |
Date Mfgr Received | 2018-06-28 |
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 |