BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1172269 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07025
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 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 17.9 MG/DL. USER STATES THEIR LIS SYSTEM CAUGHT THIS HIGH RESULT AND THEY DECIDED TO REPEAT THE SAMPLE. REPEAT RESULT 4.6 MG/DL. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS A BAD R2 PROBE AND REPLACED AND ADJUSTED IT. 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