BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALANINE AMINOTRANSFERASE (ALT) REAGENT

    MDR report key: 2292332 · Received October 13, 2011

    Report

    Report Number
    2050012-2011-06234
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IS FILING THIS MDR REPORT BECAUSE ALT REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN AND SHOULD BE CONSIDERED AS POTENTIALLY CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT 1 CARTRIDGE OF ALANINE AMINOTRANSFERASE (ALT) REAGENT WAS LEAKING FROM THE BOTTOM SEAM. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALANINE AMINOTRANSFERASE (ALT) REAGENT NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER, INC. ALT T103100

    Patients

    Seq Age Sex Outcome Treatment
    1