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 2018-03-27 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux Inc..
[103951230]
A customer in (b)(6) reported a misidentification of cryptococcus neoformans as rhodotorula minuta in association with the vitek? 2 yeast (yst) test kit (lot 2430420103). Repeat testing was not performed and the cryptococcus neoformans identification was obtained via pcr. The customer indicated there was greater than 24 hours for reporting results due to the testing performed at a reference lab. There is no indication or report from the laboratory that the discrepant result led to any 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 | 1950204-2018-00120 |
| MDR Report Key | 7373988 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-27 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2018-03-27 |
| 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 | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 | 2018-03-27 |
| Catalog Number | 21343 |
| Lot Number | 2430420103 |
| Device Expiration Date | 2019-01-20 |
| 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 | 2018-03-27 |