BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1172450 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07024
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT PHOSPHORUS RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT 11.6 MG/DL. USER STATES THEIR LIS SYSTEM CAUGHT THIS HIGH RESULT, AND THEY DECIDED TO REPEAT THE SAMPLE. REPEAT RESULT 3.3 MG/DL. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THIS WAS CAUSED BY AN IMPROPERLY FILLING CUVETTE RINSE DUE TO DIRTY AND CLOGGED LINES. HE FLUSHED AND CLEANED THE LINES. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK