BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1140541 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06522
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED DISCREPANT CALCIUM RESULTS OF TEN PATIENT SAMPLES. THE FOLLOWING PATIENT EXAMPLE WAS PROVIDED. INITIAL RESULT GAVE 7.9 MG/DL; REPEAT GAVE 8.7 MG/DL. THE CUSTOMER REPORTED THE REPEAT RESULTS, NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE REAGENT VALVE, AND CLEANED-RINSED REAGENT CHANNEL, AND PERFORMED A RINSE-PRIME ON ALL CHANNELS. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK