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 2018-05-31 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux Inc..
[110344662]
A customer in the united states reported a misidentification of a candida guilliermondii cap survey sample (f1-02), as candida famata in association with the vitek? 2 yst test kit. The customer reported candida famata as their identification. Repeat testing gave a result of low discrimination between c. Guillermondii and c. Famata. The customer submitted the lab and the cap survey reports for evaluation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1950204-2018-00201 |
MDR Report Key | 7558261 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2018-05-31 |
Date of Report | 2018-07-10 |
Date Mfgr Received | 2018-06-12 |
Device Manufacturer Date | 2018-01-07 |
Date Added to Maude | 2018-05-31 |
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 | MS. DEBRA BROYLES |
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 YST TEST KIT |
Generic Name | VITEK? 2 YST TEST KIT |
Product Code | JXB |
Date Received | 2018-05-31 |
Catalog Number | 21343 |
Lot Number | 2430590203 |
Device Expiration Date | 2019-07-09 |
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 | 2018-05-31 |