BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT KIT

    MDR report key: 2426949 · Received January 24, 2012

    Report

    Report Number
    2050012-2012-00253
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    November 4, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT. BEC IDENTIFIER FOR THIS REPORT IS (B)(4). DEFECTED DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT UPON RECEIPT OF THE SYNCHRON ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT LOT, THE CUSTOMER OBSERVED THAT ONE (1) REAGENT KIT WAS EMPTY AND WET WITH NO VISIBLE DAMAGE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT KIT NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER INC. CX/LX ALT KIT M102143

    Patients

    Seq Age Sex Outcome Treatment
    1