BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1241666 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08554
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ERRONEOUS RESULTS FOR FIVE CHEMISTRIES (CHOLESTEROL, TRIGLYCERIDE, IRON, RHEUMATOID FACTOR AND ALKALINE PHOSPHATASE) DURING A TWO DAY PERIOD. THE NUMBER OF PT SAMPLES INVOLVED IS UNK. ONE PT EXAMPLE WAS PROVIDED, THE INITIAL ERRONEOUS RESULT WAS ACCOMPANIED BY A DATA FLAG INSTRUCTING THE USER TO RERUN THE SAMPLE. THE CUSTOMER STATES THAT THE PT SAMPLES WITH THE PROBLEM CHEMISTRIES WERE CAPTURED ON PSM AND NOT RELEASED FROM THE LABORATORY. HE IS ALSO NOT AWARE FROM THE CLINICAL STAFF THAT ANY PTS HAVE RECEIVED INAPPROPRIATE TREATMENT. THE CUSTOMER WAS ADVISED A FIELD CORRECTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. IF ADDITIONAL INFO IS RECEIVED. APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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