BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1810990 · Received August 23, 2010

    Report

    Report Number
    1823260-2010-05007
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 15, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A FAILING BICARBONATE (CO2) RESULT ON A CAP SURVEY SAMPLE RUN ON A COBAS INTEGRA 800 ANALYZER. THE CUSTOMER'S RESULT WAS 13 MMOL/L AND CAP'S ACCEPTABLE RANGE WAS 17-26 MMOL/L. THE CUSTOMER STATED THAT THE SURVEY WAS RUN SOMETIME IN THE MIDDLE OF (B)(6) 2010, BUT WAS UNABLE TO SUPPLY AN EXACT DATE. NO PATIENT SAMPLES WERE INVOLVED IN THE EVENT AND NO SERIOUS ADVERSE EVENT WAS REPORTED. THE BICARBONATE REAGENT LOT NUMBER WAS EITHER 63188301 OR 61747701. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE CUSTOMER'S OBSERVATION. HE PERFORMED INSTRUMENT CHECKS AND PERFORMANCE TESTS, INCLUDING PRECISION CHECKS WITH TWO LEVELS OF CONTROL MATERIALS. THE RESULTS WERE WITHIN SPECIFICATIONS. CALIBRATION HISTORY AND QUALITY CONTROL HISTORY WERE ALSO REVIEWED AND FOUND TO BE GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1