BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINDAMYCIN CM 256 WW S30

    MDR report key: 5118070 · Received October 1, 2015

    Report

    Report Number
    3002769706-2015-00111
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Report Date
    September 14, 2015
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JWY
    PMA / PMN Number
    K913459/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE RESULTS OF THE INVESTIGATION INDICATE RESULTS AT THE LIMIT OF THE COMPATIBILITY WITH ETEST® CLINDAMYCIN CM 256 (WHATEVER THE LOT TESTED) WHEN USED IN CONJUNCTION WITH MUELLER HINTON E AGAR. THIS ALLOWS A POTENTIAL FOR THE UNDERESTIMATION OF THE MIC FOR QC STRAINS 29213 WHICH CAN GIVE SOME VALUES OUT OF RANGE. BASED ON THE INVESTIGATION RESULTS, WHEN USING ETEST® CM 256 TEST KIT IN CONJUNCTION WITH MUELLER HINTON E AGAR, THERE IS A POTENTIAL FOR LOW MIC FOR STAPHYLOCOCCUS STRAINS. INTERMEDIATE (I) STRAINS COULD GIVE A FALSE SUSCEPTIBLE RESULT (S) OR RESISTANT (R) STRAINS COULD GIVE A FALSE INTERMEDIATE RESULT (I). FIELD CORRECTIVE ACTION ((B)(4)) AND CORRESPONDING PRODUCT CORRECTION NOTICE (CUSTOMER LETTER) WERE ISSUED TO THE FIELD 14-DEC-15.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT LOW RESULTS FOR ENTEROCOCCUS ATCC9213 WITH ETEST CLINDAMYCIN CM 256 TEST KIT ((B)(4), LOT 1003765720). RETESTING PROVIDED THE SAME RESULT USING BOTH BIOMERIEUX AND OXOID ATCC 29213. THE SAME ETEST CLINDAMYCIN CM 256 PRODUCT IS MARKETED IN THE UNITED STATES UNDER (B)(4). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652063 CLINDAMYCIN CM 256 WW S30 ETEST CLINDAMYCIN 256 JWY BIOMERIEUX, SA 1003765720

    Patients

    Seq Age Sex Outcome Treatment
    1