BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM

    MDR report key: 1191545 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07212
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING ERRONEOUS RESULTS FOR ONE PATIENT WITH LIPASE. INITIAL RESULT 12 U/L, REPEAT 35 U/L AND 17 U/L. SAMPLE WAS THEN TESTED ON AN ANALYZER AT ANOTHER SITE AND GAVE RESULT OF 13 U/L. ORIGINAL VALUE IS BELIEVED TO BE CORRECT AND WAS REPORTED. NO CORRECTED REPORT WAS ISSUED. THE FIELD SERVICE REPRESENTATIVE FOUND THE LAST SQUEEGEE NOZZLE WAS STICKING IN AN UP POSITION. HE CLEANED AND ALIGNED THE NOZZLE. ON FOLLOW UP VISIT, HE NOTED THE SAMPLE PROBE RINSE STATION WATER DISPENSE WAS TOO LOW AND CLEANED THE SAMPLE RINSE LINES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 917 DISK SYSTEM CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK