BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 3522933 · Received May 24, 2013

    Report

    Report Number
    2244574-2013-00081
    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*88:01 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 1289713) RESULTS AND SBT TYPING ON A SAMPLE. THE SAMPLE TYPE AS A DPB1*03:01:01/88:01 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
    232741 DPB1 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORP 008 1289713

    Patients

    Seq Age Sex Outcome Treatment
    1