BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS

    MDR report key: 855256 · Received May 23, 2007

    Report

    Report Number
    1823260-2007-04422
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    April 27, 2007
    Report Date
    May 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJF
    PMA / PMN Number
    K851172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FIVE PT SAMPLES HAVE DISCREPANT RESULTS FOR ELECTROLYTES. THE FOLLOWING EXAMPLE WAS PROVIDED: INITIAL POTASSIUM RESULT OF 2.2 MMOL/L. SAME SAMPLE REPEATED GAVE RESULT OF 3.7 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED FOR ALL 5 SAMPLES. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISE TUBING WAS WORN. THE INSTRUMENT WAS REPAIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR