MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-04-26 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux Inc..
[107226103]
A customer in (b)(6) reported a misidentification of a candida auris strain from a patient's ear swab, as candida duobushemulonii, in association with the vitek? 2 yst test kit (lot 2430316403). The customer reported that the patient isolate was initially identified correctly as c. Auris (90%) with the yst card. However, repeat testing with the yst card identified candida duobushemulonii. The bruker id obtained identification of c. Auris but with a bad score in research use only mode. The control strain ((b)(4)) also misidentified as c. Duobushemulonii. The customer stated that the strains were tested on two different instruments, with two different lots. The media used for the first testing was pvx (chocolate agar + polyvitex) and was used after 24h co2 35? C. The retesting was done from chromid? Candida after 48h 35? C and 72h 35? C. The customer reported that patient results and treatment were not impacted. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00163 |
| MDR Report Key | 7466564 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-26 |
| Date of Report | 2018-08-28 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2017-04-08 |
| Date Added to Maude | 2018-04-26 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM RD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 2018-04-26 |
| Catalog Number | 21343 |
| Lot Number | 2430316403 |
| Device Expiration Date | 2018-10-08 |
| 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 | 2018-04-26 |