BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP ALLSET GOLD KIT

    MDR report key: 2985835 · Received February 26, 2013

    Report

    Report Number
    2244574-2013-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 25, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK070038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ATTACHED CORRECTION REPORT WHICH WAS SENT TO THE RECALL COORDINATOR ON 02/25/2013.

    Description of Event or Problem · 1

    THE DPB1 SSP ALL SET GOLD KIT HAS A FALSE NEGATIVE IN LANE 39 WHICH GIVES NO PERFECT MATCH TYPING RESULT FOR THE DPB1 135:01 ALLELE. ONE COMPLAINT REGARDING THIS ISSUE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81660 DPB1 SSP ALLSET GOLD KIT MZI TEST, QUALITATIVE FOR HLA MZI LIFE TECHNOLOGIES CORPORATION 54070D 008 1204422

    Patients

    Seq Age Sex Outcome Treatment
    1