BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX CREATININE

    MDR report key: 2495802 · Received March 19, 2012

    Report

    Report Number
    2050012-2012-00791
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGX
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE BECKMAN COULTER SITE IN (B)(6) REPORTED RECEIVING CARTRIDGES OF CREATININE REAGENT THAT HAD LEAKED UPON ARRIVAL DUE TO LOOSE CAPS. NO INJURY OR EXPOSURE WAS REPORTED BY THE WAREHOUSE OPERATOR. IT WAS DECIDED THAT AN MDR SHOULD BE FILED BECAUSE THE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN, WHICH IS CONSIDERED POTENTIALLY INFECTIOUS, AND UPON RECUR, EXPOSURE MAY CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX CREATININE ALKALINE PICRATE, COLORIMETRY, CREATININE CGX BECKMAN COULTER, INC. M107190

    Patients

    Seq Age Sex Outcome Treatment
    1