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 2016-11-08 for ETEST? VORICONAZOLE 532818 manufactured by Biomerieux, Sa.
[59570435]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[59570436]
A customer in (b)(6) reported a discrepant result (out-of-range-low) for candida albicans, atcc? 90028, associated with etest? Voriconazole vo 32 ww f100. The customer had tested two batches of voriconazole in which both gave low results. Customer stated that instead of streaking the plates, they "flow" the plates before they apply the etest?. 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. There was no patient directly associated with the neqas survey sample. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[66246764]
A biom? Rieux investigation was conducted for a discrepant result (out-of-range-low) for candida albicans, atcc? 90028, associated with etest? Voriconazole vo 32 ww f100. The investigation involved testing the etest? Voriconazole vo 32 (lot 1003390050) customer strips, retained strip samples, and a different lot as reference, with 3 atcc stains (atcc 90028 - atcc 6258 - atcc 22019). The issue observed by the customer with the quality control strains was not reproduced. The customer stated that instead of streaking the plates, they "flow" the plates before they apply the etest?. Inoculation by floating is not the recommended procedure stated in the instructions for use (package insert) and it's necessary for antifungals to swab twice. The investigation concluded the etest? Voriconazole vo 32 ww f100 is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00465 |
| MDR Report Key | 6086590 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-12 |
| Date Mfgr Received | 2016-10-12 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2016-11-08 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? VORICONAZOLE |
| Generic Name | ETEST? VORICONAZOLE |
| Product Code | JWY |
| Date Received | 2016-11-08 |
| Catalog Number | 532818 |
| Lot Number | 1004139440 |
| 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, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-08 |