BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B HIGH RES SSP UNITRAY KIT

    MDR report key: 2592310 · Received May 25, 2012

    Report

    Report Number
    2244574-2012-00004
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    March 30, 2012
    Report Date
    May 24, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. B HIGH RES SSP UNITRAY KITS HAVE A FALSE NEGATIVE IN LANE 83 FOR B 47:03 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B HIGH RES SSP UNITRAY KIT MZI, TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORP. 4730010 009 984375

    Patients

    Seq Age Sex Outcome Treatment
    1