MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® METRONIDAZOLE MZH

Catalog Number	530018
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomerieux of discrepant results associated with etestetronidazole 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.
Additional Manufacturer Narrative
An internal biomérieux 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.

• Brand Name: ETEST® METRONIDAZOLE MZH
• Common Device Name: ETEST® METRONIDAZOLE MZH
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• MDR Report Key: 5627668
• Report Number: 3002769706-2016-00081
• Device Sequence Number: 11844590
• Product Code: JWY
• Combination Product (Y/N): N
• PMA/510(K) Number: K913459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2018
• Device Catalogue Number: 530018
• Device Lot Number: 1002689900
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 07/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1