BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1172266 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07052
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT TROPONIN T RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 0.157 UG/L. SAME SAMPLE WAS REPEATED THREE TIMES GIVING 0.079, 0.085 AND 0.089 UG/L. INITIAL RESULT WAS REPORTED. NO CLINICAL INFORMATION ABOUT THE PATIENT WAS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED FROM THE CUSTOMER SIDE. THE INVESTIGATIONAL UNIT DID NOT VERIFY THE CUSTOMER COMPLAINT. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED AS DATA FROM THE TIME OF OCCURRENCE WAS UNAVAILABLE FOR FURTHER EVALUATION. THE FIELD SERVICE REPRESENTATIVE REPLACED AND ALIGNED THE BLACK TUBING TO THE MEASURING CELL. ADDITIONALLY IT WAS NOTED A SHORTER THAN ALLOWED CLOTTING TIME FOR THE SAMPLE AND TOO HIGH CENTRIFUGE SETTINGS AS A POSSIBLE ROOT CAUSE. NO FURTHER ISSUES HAVE BEEN OBSERVED BY THE CUSTOMER SINCE THE FSR SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK