BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A HIGH RES SSP UNITRAY 10TESTS

    MDR report key: 4912863 · Received July 10, 2015

    Report

    Report Number
    2244574-2015-00079
    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
    BK020068
    Removal / Correction Number
    2244574-008-2015 C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO CUSTOMER COMPLAINT (B)(6) MADE AGAINST ALLSET GOLD A HIGH SSP (SKU 54010D, 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 ALLELE WHEN THE LABELING INDICATES THE REACTIVITY SHOULD BE POSITIVE. THE LABELING DISCREPANCY MAY LEAD TO POTENTIALLY MISTYPING AN "A" 03:20 ALLELE AS AN A 03:01 ALLELE. 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 OF INCORRECT LABELING ON THE REACTIVITY FOR THE ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448627 A HIGH RES SSP UNITRAY 10TESTS MZI TEST, QUALITATIVE FOR HLA MZI LIFE TECHNOLOGIES 012 1608873

    Patients

    Seq Age Sex Outcome Treatment
    1