BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1221489 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08179
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS CALCIUM RESULTS FOR SEVERAL PT SAMPLES. TWO EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 8.2 MG/DL, REPEAT ON ANOTHER ANALYZER GAVE 9.0 MG/DL. SAMPLE 2 INITIAL RESULT 7.9 MG/DL, REPEAT ON ANOTHER ANALYZER GAVE 9.0 MG/DL. THE ERRONEOUS RESULTS WERE REPORTED AND CORRECTED. NO TREATMENT WAS RECEIVED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A DIRTY STIRRER PADDLE AND CLEANED THE STIRRER PADDLE, CHANNEL AND PROBE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK