BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN SYNCHRON CX7D

    MDR report key: 128938 · Received October 23, 1997

    Report

    Report Number
    2050012-1997-00006
    Event Type
    Malfunction
    Date Received
    October 23, 1997
    Date of Event
    October 3, 1907
    Report Date
    October 22, 1997
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A FALSELY ELEVATED CREATININE RESULT OF 8 WAS REPORTED TO THE PHYSICIAN. USER PROTOCOL TO RE-RUN ELEVATED CREATININE RESULTS OR RESULTS THAT DO NOT CORRELATE WITH THE BUN RESULT, WAS NOT FOLLOWED BY THE USER. THIS RESULT WAS ELEVATED AND DID NOT CORRELATE WITH THE PTS BUN. A RE-TEST IS NORMALLY REQUESTED UNDER THESE CIRCUMSTANCES AND A SINGLE ELEVATED CREATININE RESULT WOULD NOT BE LIKELY TO RESULT IN TREATMENT. FOR REASONS THAT ARE NOT CURRENTLY KNOWN, THE PHYSICIAN INITIATED DIALYSIS TREATMENT BASED ON THE SINGLE ELEVATED CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN SYNCHRON CX7D CLINICAL CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS, INC. CX7D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other