BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1040402 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03829
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT PHOSPHORUS RESULTS. INITIAL RESULT 16.2 MG/DL, REPEAT 3.5 MG/DL. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS A PROBLEM WITH THE REAGENT PROBE ALIGNMENT AND THE CELL RINSE MECHANISM. THE REAGENT PROBES WERE ALIGNED AND MAINTENANCE AND CHECKS WERE PERFORMED ON THE CELL RINSE MECHANISM. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK