BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1234083 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08143
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT CALCIUM AND CO2 RESULTS FOR AN UNK NUMBER OF SAMPLES. TWO PT EXAMPLES WERE PROVIDED. PT 1, MALE, INITIAL CALCIUM RESULT 7.4 MG/DL, REPEAT 8.7 MG/DL. THE INCORRECT RESULTS WERE NOT REPORTED. NO PTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED A CLOTTED WASTE VALVE TO BE THE CAUSE AND CLEANED THE WASTE LINES AND VALVES. HE RAN THE INSTRUMENT TO VERIFY PERFORMANCE.

    Description of Event or Problem · 2

    USER EXPERIENCED DISCREPANT CALCIUM AND CO2 RESULTS FOR AN UNK NUMBER OF SAMPLES. TWO PT EXAMPLES WERE PROVIDED. PT 2, FEMALE, INITIAL CO2 RESULT 36 MMOL/L, REPEAT 28 MMOL/L. THE INCORRECT RESULTS WERE NOT REPORTED. NO PTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED A CLOTTED WASTE VALVE TO BE THE CAUSE AND CLEANED THE WASTE LINES AND VALVES. HE RAN THE INSTRUMENT TO VERIFY PERFORMANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2