BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD A HIGH RES SSP

    MDR report key: 4912916 · Received July 10, 2015

    Report

    Report Number
    2244574-2015-00093
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    LIFE TECHNOLOGIES
    Product Code
    MZI
    PMA / PMN Number
    BK070038
    Removal / Correction Number
    2244574-008-2015 C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REPLICATED THE CUSTOMER'S OBSERVATION (B)(6) 2015. THE INVESTIGATION CONCLUDED ON 06/16/2015 AND WAS UNABLE TO DETERMINE WHETHER THE RESULT IS RELATED TO THE SPECIFIC DNA SAMPLE OR REFLECTIVE OR INCORRECT LABELING ON THE REACTIVITY FOR THE ALLELE.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO CUSTOMER COMPLAINT (B)(4) MADE AGAINST ALLSET GOLD A HIGH RES SSP (SKU (B)(4), LOT 012 1608823), SINCE THIS LOT CONTAINS THE SAME AFFECTED PRIMER MIX. THE CUSTOMER REPORTED THAT THE REACTIVITY FOR LANE 86 WAS NEGATIVE FOR THE A 03:20 ALELE WHEN THE LABELING INDICATES THE REACTIVITY SHOULD BE POSITIVE. THE LABELING DISCREPANCY MAY LEAD TO POTENTIALLY MISTYPING A A 03:20 ALLELE AS AN A 03:01 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448638 ALLSET GOLD A HIGH RES SSP TEST, QUALITATIVE FOR HLA MZI LIFE TECHNOLOGIES 012 1544269

    Patients

    Seq Age Sex Outcome Treatment
    1