BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DQB1 SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3915180 · Received May 16, 2014

    Report

    Report Number
    2244574-2014-00179
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Report Date
    April 28, 2014
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION TESTING WAS CONDUCTED USING THE CUSTOMER SAMPLE WITH ANOTHER LOT OF DQB1 UNITRAY KIT AND A SCORE DQB1 KIT. BOTH METHODS PRODUCED A RESULT OF DQB1:03:01, DQB1 04:02. RETAIN TESTING FOR DQB1 UNITRAY KIT, SKU 451414, LOT 015 1180483 WAS NOT POSSIBLE AS KIT IS EXPIRED. THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT OF DISCORDANT TYPING IS CUSTOMER'S MISINTERPRETATION OF THE ORIGINAL GEL (TEST) RESULTS, MISTAKING A PRIMER DIMER IN LANE 11 FOR A POSITIVE BAND. THE CUSTOMER HAS BEEN PROVIDED FOR INFORMATION TO EXPLAIN HOW TO EVALUATE TEST RESULTS WITH PRIMER DIMER GEL BANDS.

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING WHEN TESTING A SINGLE SAMPLE USING DQB1 SSP UNITRAY KIT WITH TAQ, SKU 451414, LOT 0151180483, SHE OBTAINED A TYPING RESULT OF DQB1 03:09, 04:02. CUSTOMER LATER TESTED THE SAME SAMPLE USING A DIFFERENT LOT OF DQB1 SSP UNITRAY KIT WITH TAQ, SKU 451414 AND RECEIVED A TYPING OF: DQB1 03:01, 04:02. CUSTOMER WAS QUESTIONING THE DISCREPANCY OF THE TEST RESULTS, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293271 DQB1 SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-D MZI LIFE TECHNOLOGIES CORPORATION 015 1180483

    Patients

    Seq Age Sex Outcome Treatment
    1