BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1140547 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06527
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT SODIUM AND OR POTASSIUM RESULTS. THE FOLLOWING PATIENT EXAMPLE WAS PROVIDED. INITIAL SODIUM GAVE 68 MMOL/L; REPEATED TWICE GIVING 143 AND 141 MMOL/L. INITIAL POTASSIUM GAVE 1.7 MMOL/L; REPEATED TWICE GIVING 3.4 MMOL/L BOTH TIMES. USER INDICATED REPEAT RESULTS WERE REPORTED, ERRONEOUS RESULTS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ISE TUBING AND REPLACED. 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 I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK