BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1 04 SSP UNITRAY KIT

    MDR report key: 2844211 · Received November 8, 2012

    Report

    Report Number
    2244574-2012-00007
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    July 30, 2012
    Report Date
    November 7, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. DRB1 04 SSP UNITRAY KIT HAS A (B)(6) IN LANE 9, WHICH GIVES NO PERFECT MATCH TYPING RESULT FOR THE DRB1 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRB1 04 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN IYO LIFE TECHNOLOGIES CORPORATION 450404 011 989163

    Patients

    Seq Age Sex Outcome Treatment
    1