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 2016-04-28 for ETEST? METRONIDAZOLE MZH 530018 manufactured by Biomerieux, Sa.
[44003359]
A customer in sweden notified biom? Rieux of a discrepant results associated with etest? Metronidazole mzh 256 (reference 530018). The customer reported always getting low minimal inhibitory concentration (mic) when doing controls. The customer identified the control strain as e. Coli atcc 25285. The approved spreading interval was 0. 25-1 mg/l and an anaerobe plate without antibiotics was utilized. An investigation into the event will be initiated by biomerieux.
Patient Sequence No: 1, Text Type: D, B5
[51263432]
An investigation into a discrepant result event while using the etest? Metronidazole was performed. The customer did not return their strain for testing at biomerieux. Quality control samples with atcc? 25922, atcc? 29741 and atcc? 25285 were run with retain samples from five (5) lots etest? Metronidazole test kits. The results of all testing were within specifications for all samples. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00076 |
| MDR Report Key | 5616965 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-28 |
| Date of Report | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-04-28 |
| 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? METRONIDAZOLE MZH |
| Generic Name | ETEST? METRONIDAZOLE MZH |
| Product Code | JWY |
| Date Received | 2016-04-28 |
| Catalog Number | 530018 |
| Lot Number | 1003409180 |
| Device Expiration Date | 2019-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-04-28 |