BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 3522938 · Received May 24, 2013

    Report

    Report Number
    2244574-2013-00079
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 13, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Removal / Correction Number
    006-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION CONFIRMED CUSTOMER COMPLAINT OF FALSE NEGATIVE IN LANES 27 AND 39 WITH THE DPB1 (B)(4) ALLELE. ROOT CAUSE IS DETERMINED TO BE INCORRECT REACTIVITY PREDICTION FOR THIS ALLELE WITH THESE LANES. RECALL #006-2013. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A DISCREPANCY BETWEEN THE DPB1 UNITRAY SSP (MODEL #451606D LOT #008 1190373) RESULTS AND SBT TYPING ON A SAMPLE. THE SAMPLE TYPE AS A DPB1 (B)(4) BY SEQUENCING. DPB1 HIGH RESOLUTIONS SSP TRAY DID NOT GIVE A RESULT. CUSTOMER INDICATED THAT WELLS 27 AND 39 WERE FALSE NEGATIVE. THIS LED TO A NO TYPE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232742 DPB1 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORP 008 1190373

    Patients

    Seq Age Sex Outcome Treatment
    1