BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON AST

    MDR report key: 2478722 · Received March 5, 2012

    Report

    Report Number
    2050012-2012-00652
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2012, CUSTOMER REPORTED THAT THEY RECEIVED A CARTRIDGE OF ASPARTATE AMINOTRANSFERASE REAGENT THAT HAD LEAKED. NO INJURY WAS REPORTED DUE TO THE EXPOSURE. THE LEAK WAS DUE TO THE BOTTOM SEAM OF THE REAGENT CARTRIDGE. IT WAS DECIDED THAT AN MDR SHOULD BE FILED BECAUSE THE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN, AND UPON RECUR, UNPROTECTED EXPOSURE IS POTENTIALLY INFECTIOUS AND MAY CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON AST NADH OXIDATION/NAD REDUCTION, AST/SGOT CKA BECKMAN COULTER, INC. M201056

    Patients

    Seq Age Sex Outcome Treatment
    1