BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193386 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07407
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED LOW RESULTS FOR SODIUM AND POTASSIUM FOR SEVERAL PT SAMPLES. USER ESTIMATED MORE THAN 10 SAMPLES WERE AFFECTED. ONE EXAMPLE WAS PROVIDED. INITIAL SODIUM RESULT 99 MMOL/L, REPEAT 135 MMOL/L; INITIAL POTASSIUM 3.4 MMOL/L, REPEAT 4.3 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A CLOT IN THE MIXTOWER AND CLEANED THE MIXTOWER. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK