BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1140550 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06530
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCING DISCREPANT CALCIUM RESULTS SINCE 2008. ON THE FOLLOWING MONTH, THREE PATIENT SAMPLES GENERATED A > 15 MG/DL DIFFERENCE BETWEEN INITIAL AND REPEAT TESTING. EXACT NUMBER OF PATIENT SAMPLES AND SPECIFIC PATIENT DATA WAS NOT PROVIDED. NO ERRONEOUS RESULTS REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE MULTIPLE WORKSTATIONS OUT OF ADJUSTMENT AND WORN ROTOR MOTOR. REPLACED ROTOR BELT AND ROTOR MOTOR AND ADJUSTED LIGHT BARRIER. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK