BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1162211 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06926
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED PROBLEMS WITH BUN APPLICATION FOR TWO DAYS. TOTAL NUMBER OF PATIENT SAMPLE AFFECTED WAS NOT GIVEN. ONE EXAMPLE PROVIDED, WHICH OCCURRED IN 2008. INITIAL RESULT 2 MG/DL, REPEAT 105 MG/DL. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE ISSUE WAS DUE TO CONTAMINATION AND CLEANED THE REGENT LINES, NOZZLES AND SAMPLE PROBES. HE ALSO NOTED HE CHECKED THE CELL WASH MECHANISM. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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