BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON POTASSIUM

    MDR report key: 1766180 · Received October 11, 2007

    Report

    Report Number
    1823260-2007-08878
    Event Type
    Malfunction
    Date Received
    October 11, 2007
    Date of Event
    September 17, 2007
    Report Date
    October 11, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CEJ
    PMA / PMN Number
    K904033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED 3 PATIENT SAMPLES WITH DISCREPANT POTASSIUM RESULTS BETWEEN 2 DIFFERENT METHODS AS FOLLOWS: SAMPLE 1, INITIAL RESULT 4.69 MMOL/L, REPEAT USING DIFFERENT METHOD 5.4 MMOL/L. SAMPLE 2, INITIAL RESULT 3.33 MMOL/L, REPEAT USING DIFFERENT METHOD 4.5 MMOL/L. SAMPLE 3, INITIAL RESULT 3.93 MMOL/L, REPEAT USING DIFFERENT METHOD 4.6 MMOL/L. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON POTASSIUM CLINICAL CHEMISTRY ANALYZER - CEJ CEJ ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK