BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1213751 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07796
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER STATES SEVERAL PATIENT SAMPLES WERE AFFECTED WITH ERRONEOUS RESULTS FOR MULTIPLE ASSAYS FOR APPROXIMATELY 1 WEEK. TOTAL NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT PROVIDED. ONE GENERAL EXAMPLE FOR CALCIUM WAS PROVIDED. INITIAL RESULT WAS 5-8 MG/DL BELOW NORMAL THAT REPEATED IN THE NORMAL RANGE OF 806-10.2 MG/DL. NONE OF THE ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS THE AGE OF THE PROBES AND CHANGED THEM. PERFORMANCE TESTS WERE PERFORMED.

    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