BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 2985868 · Received February 26, 2013

    Report

    Report Number
    2244574-2013-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 25, 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

    Description of Event or Problem · 1

    THE DEPBI SSP UNITRAY KIT HAS A FALSE NEGATIVE IN LANE 30 WHICH GIVES NO PERFECT MATCH TYPING RESULT FOR THE DPB1 29:01 ALLELE. ONE COMPLAINT REGARDING THIS ISSUE HAS BEEN RECEIVED. CONNECTION REPORT WHICH WAS SENT TO THE RECALL COORDINATOR ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81760 DPB1 SSP UNITRAY KIT MZI TEST, QUALITITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 451606D 008 1103716

    Patients

    Seq Age Sex Outcome Treatment
    1