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 2018-06-12 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biom?rieux, Inc..
[111447509]
A customer in the united states notified biom? Rieux of a misidentification of cap survey strain candida guilliermondi in association with the vitek? 2 yeast (yst) identification (id) test kit. The vitek 2 yst id card identified the strain to candida famata. Repeat test obtained the same result. The customer submitted the identification of candida famata to cap. Cap indicated the result to be incorrect; candida guilliermondi was the expected result. The customer stated they plate the direct specimen, sub-culture it once, then test on the vitek 2 system according to cap instructions. Following receipt of the cap answer, the customer performed testing on the cap strain via vitek ms, and obtained the expected result of candida guilliermondi. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any person's state of health, as there is no patient associated with the cap survey strain, biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00221 |
| MDR Report Key | 7590866 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-12 |
| Date of Report | 2018-07-23 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2016-11-10 |
| Date Added to Maude | 2018-06-12 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 CARD |
| Product Code | JXB |
| Date Received | 2018-06-12 |
| Catalog Number | 21343 |
| Lot Number | 2430167403 |
| Device Expiration Date | 2018-05-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-12 |