BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1082720 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05719
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS MULTIPLE SAMPLES FOR SODIUM RECOVERING 127-130 MMOL/L WHEN THEY WERE EXPECTED TO RECOVER 136-145 MMOL/L. NO SPECIFIC DATA COULD BE PROVIDE. NO ADVERSE EVENTS REPORTED. THE REFERENCE ELECTRODE AND ISE SOLUTIONS 1 AND 2 WERE REPLACED WHICH IMPROVED PERFORMANCE OF THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK