BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1945187 · Received January 3, 2011

    Report

    Report Number
    1319681-2011-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 11, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THE RESULT IN QUESTION WAS CAUSED BY AN ANALYZER OR REAGENT MALFUNCTION. THE SAMPLE IN QUESTION WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TSH RESULT FROM A SINGLE PATIENT SAMPLE WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS UNKNOWN IF THE HIGHER THAN EXPECTED TSH PATIENT RESULT WAS REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1