BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON (R) SYSTEMS CREATININE REAGENT

    MDR report key: 2148204 · Received July 2, 2011

    Report

    Report Number
    2050012-2011-02645
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGX
    PMA / PMN Number
    K071283
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAK OCCURED DUE TO BROKEN/CRACKED CAPS. NO ADDITIONAL INFORMATION IS AVAILABLE. TOTAL MICROPROTEIN INFORMATION: CATALOG NUMBER: 445860, LOT NUMBER: M103285, DATE OF MANUFACTURE: 03/23/2011, EXPIRATION DATE: 09/30/2012. BRAND NAME: BIURET (COLORIMETRIC), TOTAL PROTEIN, COMMON DEVICE NAME: TOTAL PROTEIN TEST SYSTEM. CLASSIFICATION CODE:CEK, 510K NUMBER: K914885.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC (BEC) (B)(4) REPORTED RECEIVING CREATININE REAGENT AND TOTAL MICROPROTEIN REAGENT CARTRIDGES THAT LEAKED. PERSONAL PROTECTIVE EQUIPMENT WAS USED WHEN HANDLING THE CARTRIDGE. NO INJURY OR EXPOSURES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON (R) SYSTEMS CREATININE REAGENT CREATININE TEST SYSTEM. CGX BECKMAN COULTER INC. N/A M104132

    Patients

    Seq Age Sex Outcome Treatment
    1