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 2017-12-18 for VITEK? 2 AST-YS08 TEST KIT. 420739 manufactured by Biomerieux, Inc.
[96024208]
A customer from the (b)(6) reported to biom? Rieux an out of range low (oorl) fluconazole result for a candida krusei quality control strain (atcc 62058), in association with the vitek? 2 ast-ys08 test kit. The customer tested the strain twice, by using the ast-ys08 card on two different instruments. The result was mic = 4 for both tests with the expected range of mic 8 >/= 64. There was no patient involvement as the event pertained to a quality control sample. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00461 |
| MDR Report Key | 7125873 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-18 |
| Date of Report | 2018-05-18 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-12-18 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 AST-YS08 TEST KIT. |
| Generic Name | VITEK? 2 AST-YS08 TEST KIT. |
| Product Code | NGZ |
| Date Received | 2017-12-18 |
| Catalog Number | 420739 |
| Lot Number | 2880150203 |
| ID Number | 03573026535353 |
| Device Expiration Date | 2018-04-25 |
| 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 | 2017-12-18 |