BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1230994 · Received October 28, 2008

    Report

    Report Number
    1823260-2008-07979
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    July 22, 2008
    Report Date
    October 28, 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 ANALYZER GIVING ABNORMAL RESULTS FOR MULTIPLE ASSAYS. UPON INVESTIGATION, IT WAS NOTED THE K FACTORS WERE INCORRECT. AFTER RECALIBRATION, THE K FACTORS WERE CORRECTED AND SAMPLES WERE REPEATED WITH CORRECTED VALUE. ACTUAL PT DATA WAS NOT PROVIDED. NO INFO PROVIDED TO DETERMINE OF PTS WERE ADVERSELY AFFECTED DUE TO THIS ISSUE. THE INVESTIGATIONAL UNIT DETERMINED THE ROOT CAUSE IS A TIMING CONFLICT WHEN WRITING REAGENT AND CALIBRATION PARAMETER INFO TO THE HARD DISK. CUSTOMER WILL BE INFORMED BY FIELD SAFETY NOTICE.

    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