BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1780198 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08253
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT RESULTS. PT 1, INITIAL CREATININE RESULT 2.5 MG/DL, SAME SAMPLE REPEATED ON DIFFERENT INSTRUMENT GAVE RESULT OF 0.9 MG/DL. PT 2, INITIAL PHOSPHORUS RESULT OF 11.0 MG/DL. SAME SAMPLE REPEATED ON SAME INSTRUMENT GAVE RESULT OF 4.6 MG/DL. SAME SAMPLE REPEATED ON DIFFERENT INSTRUMENT GAVE RESULT OF 4.7 MG/DL. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS A PROBLEM WITH THE REAGENT PROBE ALIGNMENT. THE INSTRUMENT WAS REPAIRED.

    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 NA