BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION AR CLINICAL CHEMISTRY SYSTEM

    MDR report key: 44650 · Received September 26, 1996

    Report

    Report Number
    1225153-1996-00001
    Event Type
    Malfunction
    Date Received
    September 26, 1996
    Date of Event
    August 29, 1996
    Manufacturer
    DADE CHEMISTRY SYSTEMS INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ELEVATED POTASSIUM VALUES WERE OBTAINED ON TWO PT SAMPLES WHICH WHEN REPEATED GAVE NORMAL VALUES. NORMAL VALUES WERE CONFIRMED ON ANOTHER ANALYZER. THE PROBLEM WAS TRACED TO A FLOW PROBLEM RELATED TO THE PINCH VALVE ASSEMBLY. NO ACTION WITH RESPECT TO PT TREATMENT WAS TAKEN BASED ON THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION AR CLINICAL CHEMISTRY SYSTEM DISCRETE PHOTOMETRIC ANALYZER JJC DADE CHEMISTRY SYSTEMS INC. AR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR BECKMAN CX3