BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABDR SSP UNITRAY

    MDR report key: 3599215 · Received November 26, 2013

    Report

    Report Number
    2244574-2013-00130
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK000019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN MAYO ARIZONA OBSERVED A DISCREPANT TYPING RESULT WHEN USING ABDR SSP UNITRAY (CATALOG # 7810010 LOT# 036 1316325) TO TEST A SAMPLE KNOWN TO BE TYPED AS B 82:01. THE DISCREPANT TYPING RESULT WOULD BE CONSIDERED A MISTYPE. THIS EVENT IS DOCUMENTED IN CUSTOMER COMPLAINT PR# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617041 ABDR SSP UNITRAY MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP. 036 1316325

    Patients

    Seq Age Sex Outcome Treatment
    1