BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY

    MDR report key: 2854493 · Received November 29, 2012

    Report

    Report Number
    2244574-2012-00008
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 6, 2012
    Report Date
    November 29, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATIO
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION REPORT WAS SENT TO THE RECALL COORDINATOR ON (B)(4) 2012.

    Description of Event or Problem · 1

    THE DPB1 SSP UNITRAY KIT HAS A FALSE NEGATIVE IN LANES 27, 30 AND 39 WHICH GIVES NO PERFECT MATCH TYPING RESULT FOR THE DPB1 5.:01 ALLELE. ONE COMPLAINT REGARDING THIS ISSUE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPB1 SSP UNITRAY MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORPORATIO 451606D 008 1049949

    Patients

    Seq Age Sex Outcome Treatment
    1