BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1780971 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06551
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATED THEY HAVE BEEN GETTING ERRATIC CO2 RESULTS AND GAVE THE FOLLOWING EXAMPLE. INITIAL 45 MMOL/L REPEATED AS 24 MMOL/L. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP FOUND THE GEAR PUMP AND VACUUM VALVE WERE BAD AND REPAIRED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA