BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1181083 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07246
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER HAVING ISSUES WITH AMYLASE ASSAY CALIBRATION SINCE MID-AUG. AT ABOUT THREE WEEKS LATER, FIVE PATIENT SAMPLES HAD DISCREPANT RESULTS WHEN REPEATED AFTER ORIGINAL RESULTS WERE QUESTIONED BY A PHYSICIAN. THREE EXAMPLES WERE PROVIDED. SAMPLE 1, INITIAL RESULT 778 U/L, REPEAT 101 U/L. SAMPLE 2, INITIAL RESULT 615 U/L, REPEAT 64 U/L. SAMPLE 3, INITIAL RESULT 549 U/L, REPEAT 55 U/L. INITIAL RESULTS WERE REPORTED. PATIENTS WERE NOT ADVERSELY AFFECTED. USER RECALIBRATED THE ASSAY AND QC AND PATIENT RECOVERED WITHIN RANGE. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE PROBLEM, BUT RAN PERFORMANCE TESTS ON THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER-CEM JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK