BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 3409556 · Received September 24, 2013

    Report

    Report Number
    2244574-2013-00009
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Report Date
    June 13, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION CONFIRMED CUSTOMER RESULTS. PRIMER (B)(4) INCORRECTLY ESTIMATED THE REACTIVITY AS POSITIVE FOR DPB1 06:01 AND DPB1 29:01, THEREBY LEADING TO THE POSITIVE RESULT IN MIX (B)(4). LABELING CORRECTION ACTIVITIES FOR PRIMER (B)(4) ARE IN PROCESS AND WILL BE REPORTED IN THE 30-DAY REPORT.

    Description of Event or Problem · 1

    (B)(6) FROM (B)(6) UNIVERSITY INDICATED THAT DURING TESTING OF PT SAMPLE (B)(4), USING DPB1 SSP UNITRAY KIT (CAT # 451606D LOT # 008 1190373), DPB1 06:01 AND DPB1 29:01 HAD A POSITIVE LANE PATTERN 1,9,12,17,18,19,20,21,26,43 WHICH RESULTED IN A "NO TYPE" RESULT. THIS PATTERN CONFLICTED WITH ONE LAMBDA LAP TYPE RESULTS FOR DPB1 06:01 AND DPB1 29:01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483158 DPB1 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 008 1190373

    Patients

    Seq Age Sex Outcome Treatment
    1