BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1003486 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01751
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED 9 OCCURRENCES OF DISCREPANT CALCIUM RESULTS SINCE 2006. NO SPECIFIC INFO PROVIDED REGARDING EACH OF THOSE OCCURRENCES. THE FOLLOWING DATA WAS PROVIDED, WHICH OCCURRED IN EARLY 2008, EACH SAMPLE WAS REPEATED TWICE, FIRST REPEAT ON THE SAME ANALYZER, SECOND REPEAT ON DIFFERENT ANALYZER USING SAME METHODOLOGY. UNITS OF MEASURE = MG/DL. SAMPLE 1; INITIAL RESULT 10.1, FIRST REPEAT 8.9, AND SECOND REPEAT 8.8. SAMPLE 2; INITIAL RESULT 10.5, FIRST REPEAT 9.5, AND SECOND REPEAT 9.7. SAMPLE 3; INITIAL RESULT 10.8, FIRST REPEAT 10.0, AND SECOND REPEAT 10.0. SAMPLE 4; INITIAL RESULT 9.9, FIRST REPEAT 9.1, AND SECOND REPEAT 9.1. SAMPLE 5; INITIAL RESULT 9.9, FIRST REPEAT 9.1, AND SECOND REPEAT 9.0. SAMPLE 6; INITIAL RESULT 10.5, FIRST REPEAT 9.5, AND SECOND REPEAT 9.4. SAMPLE 7; INITIAL REPEAT 10.0, FIRST REPEAT 9.2, AND SECOND REPEAT 9.3. ERRONEOUS RESULTS WERE REPORTED, PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    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