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 2018-05-23 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux Inc..
[109505587]
A customer from the united states reported a yeast misidentification for a cap survey sample ((b)(6)) in association with the vitek? 2 yst test kit (lot #2430541203). The customer stated both samples from the two loops received, were initially identified as candida famata with the vitek yst card. After receiving the expected cap result of c. Guilliermondii, the customer retested from both loops with a different yst card (lot #2430611103) and received a low discrimination c. Guillmondo/famata. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00195 |
| MDR Report Key | 7536764 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-23 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-11-19 |
| Date Added to Maude | 2018-05-23 |
| 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 | 2018-05-23 |
| Catalog Number | 21343 |
| Lot Number | 2430541203 |
| Device Expiration Date | 2019-05-21 |
| 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 | 2018-05-23 |