BEUDAMED
    FDA Adverse Event Other Summary report: N

    3MM

    MDR report key: 1673446 · Received April 30, 2010

    Report

    Report Number
    MW5015782
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 29, 2010
    Manufacturer
    3M HEALTHCARE
    Product Code
    FRC
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEST READ POSITIVE WHEN ALL OTHERS RUN IN SAME AUTOCLAVE WITH SAME READERS READ NEGATIVE. SUSPECT VIAL WAS CONTAMINATED. ALL NEGATIVE TEST WERE FROM A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3MM ATTEST RAPID READOUT BIOLOGICAL INDICATOR FRC 3M HEALTHCARE 2011-10TD

    Patients

    Seq Age Sex Outcome Treatment
    1