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 2017-01-06 for ETEST? VORICONAZOLE 412490 manufactured by Biomerieux, Sa.
[64132872]
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 s30. The customer reported obtaining an unusual shape result, and the ellipse meets the strip under the lower mic. There are three (3) patients involved in this event with three (3) different sample types; pus, trachea aspiration and catheter. The customer reported the iqc result is not good; the expected range is 0. 004 - 0. 016 and a mic result obtain was lower than 0. 002. 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 may be a potential for adverse event if the event were to reoccur while testing a patient isolate; therefore this event is being reported as a malfunction. Culture submittal was requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75934259]
Biom? Rieux conducted an internal investigation: biom? Rieux performed an investigation on customer strips of lot 1004803990 and the retained samples from lot 1004803990 and lot 1005016560 mentioned by customer in parallel with another batch as a reference. We did not reproduce the issue observed by the customer on atcc strain 90028. The conformity of batches 1004803990 and 1005016560 mentioned by customer was be confirmed with two (2) others qc stains whose candida parapsilosis atcc 22019 and candida krusei atcc 6258. On three (3) clinical strains, we reproduced the customers results with mic very low or ellipse which ends below the strip (less than 0. 002) randomly. The strains were susceptible. We confirmed the variability of results obtained by the customer. But the result is considered as acceptable. These results are linked to normal variability intra or inter-batches for antifungals. Indeed, this variability is accepted within two (2) doubling dilutions ((b)(4)) unlike antibiotics. However, these strains have mic very low at the limit of etest? Strip mic. These strains are very susceptible. In this case the real mic do not have a clinical interest. It's the same thing with high level of mic. The variability increase at the limit of the strips (close to 0. 002 or close to 32mg/l).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00003 |
| MDR Report Key | 6230904 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-06 |
| Date of Report | 2017-05-10 |
| Date Mfgr Received | 2017-04-14 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2017-01-06 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 2017-01-06 |
| Catalog Number | 412490 |
| Lot Number | 1004803990 |
| 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 | 2017-01-06 |