BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYZER

    MDR report key: 1030593 · Received April 16, 2008

    Report

    Report Number
    1823260-2008-03280
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT POTASSIUM RESULTS FOR APPROX 10 PTS SAMPLES. IT WAS NOTED ALL PTS RAN LOW, AND WHEN REPEATED, RESULTS WERE IN THE RANGE OF 4.3-4.5 MMOL/L. ONLY THE FOLLOWING SPECIFIC EXAMPLE WAS PROVIDED: INITIAL RESULT 0.2 MMOL/L, REPEAT 4.3 MMOL/L. INITIAL RESULT WAS NOT REPORTED. THE USER CHANGED THE SAMPLE PROBE WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYZER CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR ANALYZER

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK