BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1221495 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08184
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT CALCIUM RESULTS FROM ONE PT SAMPLE. INITIAL RESULT WAS 10.8 MG/DL, REPEAT RESULT IN 2008 WAS 9.2 MG/DL TWICE. INITIAL RESULT WAS REPORTED. PT WAS NOT TREATED AS A RESULT OF THE ORIGINAL RESULT. THE FIELD SERVICE REPRESENTATIVE COULD NOT VERIFY AN EXACT CAUSE, BUT FOUND PARTICULATE MATTER IN THE SAMPLE AND A GEL LIKE SUBSTANCE ADHERING TO THE SAMPLE PROBE TIPS. HE NOTED THE SAMPLING PRECISION FAILED PERFORMANCE CHECKS AND REPLACED THE SAMPLE PROBES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR