BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS

    MDR report key: 1022430 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02787
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K920402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS DISCREPANT SODIUM AND POTASSIUM RESULTS. TWO PT EXAMPLES PROVIDED: PT 1, TESTED IN 2008, POTASSIUM INITIAL RESULT 11.5 MMOL/L; REPEATED THREE TIMES GIVING 9.8 MMOL/L TWICE, AND 4.0 MMOL/L. PT 2, TESTED THE FOLLOWING DAY, SODIUM INITIAL RESULT 99 MMOL/L; REPEATED TWICE GIVING 150 MMOL/L BOTH TIMES. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE WASTE PUMP TO BE THE CAUSE AND REPLACED THE PUMP. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS MIRA PLUS CLINICAL CHEMISTRY ANALYZER -J JJE ROCHE DIAGNOSTICS MIRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK