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 2016-05-03 for ETEST? METRONIDAZOLE MZH 530018 manufactured by Biomerieux, Sa.
[44387165]
A customer in (b)(6) notified biomerieux of discrepant results associated with etestetronidazole mzh 256 (reference 530018). The customer reported low minimum inhibitory concentration (mic) results involving a control strain escherichia coli atcc 25285. An investigation into the event will be initiated by biomerieux.
Patient Sequence No: 1, Text Type: D, B5
[49513878]
An internal biom? Rieux investigation was conducted due to low mic results with b. Fragilis atcc 25285 on etest? Metronidazole mzh 256 ww f100 ref 530018. Lots tested: 1002689900, 1003007690, 1003409180, 1003827270. A reference lot was also used for testing. Due to the absence of customer return, testing was only done on retention lots. Customer results: agar : home-made (anaeroplates without antibiotics), oxoid or bd. Results below the range for the strain atcc 25285 e. Coli. Deviations: use of 0. 85% nacl for the suspension instead of broth of brucella mh, incubation time of 18 hours. Unconfirmed at 48 hours. Use of mueller hinton. Investigation results: at 24 hours of incubation with lot 1003409180, results of atcc 29741 and atcc 25285 are orl in comparison to the ranges at 48 hours of incubation. Ranges for 24 hours incubation don't exist. Conclusion: following investigation several hypotheses were formulated that could explain the issue observed by the customer old investigation on etest? Metronidazole showed results orl for b. Fragilis atcc 25285 after 24 hours incubation. For anaerobe strains: media: brucella agar- 5% blood-vitamin k (mcg/ml)- hemin (5mcg/ml) and not mueller hinton agar. Inoculum suspension should be prepared in brucella broth, mh broth or schaedler broth + vitamin k3. (0. 85% nacl should not be used). Qc ranges are validated after 48 hours of incubation, not at 24 hours. In addition, other recommendations for anaerobes were included: for patient strains all "s" results must be confirmed at 48 hours of incubation. Do not vortex. Anaerobiosis must be achieve within 1-2 hours for metronidazole. In conclusion, the results of the microbiological quality control are in accordance with the expected specifications for all batches on e. Coli atcc 25922, b. Thetaiotaomicron atcc 29741 and b. Fragilis atcc 25285 after 48 hours of incubation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00081 |
| MDR Report Key | 5627668 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-03 |
| 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 | MR. JONATHAN NONNEMACHER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196203396 |
| 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 | 2016-05-03 |
| Catalog Number | 530018 |
| Lot Number | 1002689900 |
| Device Expiration Date | 2018-10-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-05-03 |