BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT

    MDR report key: 2421606 · Received January 19, 2012

    Report

    Report Number
    2050012-2012-00189
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT WHEN SHE TRIED TO OPEN THE LID OF A NEW CREATINE KINASE (CK) REAGENT, SHE DISCOVERED THAT THE REAGENT HAD LEAKED FROM THE COMPARTMENTS B AND C. 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 SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA BECKMAN COULTER, INC. M104450

    Patients

    Seq Age Sex Outcome Treatment
    1