BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1533005 · Received November 5, 2009

    Report

    Report Number
    1823260-2009-07621
    Event Type
    Malfunction
    Date Received
    November 5, 2009
    Date of Event
    October 13, 2009
    Report Date
    November 5, 2009
    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

    CUSTOMER HAD A PROBLEM WITH URIC ACID RESULTS. SHE PROVIDED RESULTS FOR SIX PATIENTS, THE FOLLOWING THREE RESULTS WERE DISCREPANT: PATIENT 1, INITIAL URIC ACID RESULT 0.7 (ACCOMPANIED BY L DATA FLAG INDICATING LOW RESULT), REPEATED ON SAME ANALYZER GAVE 4.7 MG PER DL. PATIENT 2, INITIAL URIC ACID RESULT 1.2 (ACCOMPANIED BY L DATA FLAG INDICATING LOW RESULT), REPEATED ON SAME ANALYZER GAVE 8.9 MG PER DL. PATIENT 3, INITIAL URIC ACID RESULT GAVE 1.2 (ACCOMPANIED BY L DATA FLAG INDICATING LOW RESULT), REPEATED ON SAME ANALYZER GAVE 4.3 MG PER DL. SAMPLE TYPE WAS SERUM. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE RINSE MECHANISM SOLUTION WAS DRIPPING. HE FLUSHED RINSE MECHANISM, BLANK, CLEANER AND DETERGENT LINES. HE VERIFIED ANALYZER OPERATION BY RUNNING CALIBRATIONS AND QC AND OBSERVING ALL CHECKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK