BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A19 ALLSET GOLD SSP KIT

    MDR report key: 2750512 · Received September 14, 2012

    Report

    Report Number
    2244574-2012-00006
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    May 7, 2012
    Report Date
    September 12, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK070038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION HAS CONFIRMED THAT PRIMER MIX A 74-01 FOUND IN LANE 30 IN THE A19 ALLSET GOLD AND SSP UNITRAY KITS GIVES A FALSE NEGATIVE FOR THE A74:06 ALLELE ACCORDING TO THE DOCUMENTATION WITHIN THE KITS. HOWEVER, THE PRIMER MIX A 74-01 IS FUNCTIONING AS ORIGINALLY DESIGNED. A HUMAN ERROR RESULTED IN A MANUAL CHANGE OF THE A 74-01 PRIMER MIX TO BE LISTED AS POSITIVE FOR THE A74:06 ALLELE WITHIN KIT DOCUMENTATION AND THE KIT UCH FILE.

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. THE A19 ALLSET GOLD SSP KIT HAS A FALSE NEGATIVE IN LANE 30 FOR THE A7406 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A19 ALLSET GOLD SSP KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORPORATION 54130D 007 1025616

    Patients

    Seq Age Sex Outcome Treatment
    1