BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1080668 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05647
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 22, 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 REPORTS AN ISSUE WITH DISCREPANT CALCIUM AND CPK RESULTS. FOUR EXAMPLES PROVIDED. SAMPLE 1. INITIAL CPK RESULT OF 178 U/L, REPEAT 46 U/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED RINSE NOZZLES WERE NOT RELEASING COMPLETELY AND REMOVED AND CLEANED THE NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    USER REPORTS AN ISSUE WITH DISCREPANT CALCIUM AND CPK RESULTS. FOUR EXAMPLES PROVIDED. SAMPLE 2. INITIAL CALCIUM RESULT OF 4.6 MG/DL, REPEAT 8.1 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED RINSE NOZZLES WERE NOT RELEASING COMPLETELY AND REMOVED AND CLEANED THE NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    USER REPORTS AN ISSUE WITH DISCREPANT CALCIUM AND CPK RESULTS. FOUR EXAMPLES PROVIDED. SAMPLE 3. INITIAL CALCIUM RESULT OF 3.4 MG/DL, REPEAT 9.6 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED RINSE NOZZLES WERE NOT RELEASING COMPLETELY AND REMOVED AND CLEANED THE NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    USER REPORTS AN ISSUE WITH DISCREPANT CALCIUM AND CPK RESULTS. FOUR EXAMPLES PROVIDED. SAMPLE 4. INITIAL RESULT 1.8 MG/DL, REPEAT 9.8 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED RINSE NOZZLES WERE NOT RELEASING COMPLETELY AND REMOVED AND CLEANED THE NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR
    2 62 YR
    3 49 YR
    4 67 YR