BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINOCYCLINE MC 256 US S30

    MDR report key: 5101025 · Received September 24, 2015

    Report

    Report Number
    3002769706-2015-00099
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K99097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF MANUFACTURING QC RECORDS INDICATED PROPER PRODUCT PERFORMANCE WITH NO ABNORMALITIES NOTED. TESTING OF THE ETEST MINOCYCLINE WITH ATCC STRAIN SUBMITTALS AND INTERNAL ATCC STOCK PROVIDED MINOCYCLINE RESULTS IN THE HIGH END OF THE RANGE WITHIN SPECIFICATION. WHEN MACRO COLONIES APPEAR, RESULTS CAN BE ABOVE THE RANGE. THIS OCCURRENCE IS VERY RARE. ETEST MINOCYCLINE PERFORMANCE IS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THEY ARE USING REF. 412407, ETEST MINOCYCLINE MC 256 US S30 STRIPS WHICH ARE ALWAYS AT THE HIGH END OF ACCEPTABLE RANGE (1 - 1.5). CUSTOMER HAS TWO BOXES OF SAME LOT AND HAS REPEATED QUALITY CONTROL TESTING WITH THE SAME HIGH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631296 MINOCYCLINE MC 256 US S30 MINOCYCLINE MC 256 US S30 JWY BIOMERIEUX SA 1003729230

    Patients

    Seq Age Sex Outcome Treatment
    1