BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2033294 · Received March 30, 2011

    Report

    Report Number
    1319681-2011-00065
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS BHCG RESULTS OCCURRED ON MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A LIKELY ASSIGNABLE CAUSE COULD NOT BE DETERMINED. NO PRE-ANALYTICAL USER ERROR INVOLVING SAMPLE PROCESSING; NOR HAS AN INSTRUMENT OR REAGENT MALFUNCTION BEEN DETERMINED TO BE A CONTRIBUTING FACTOR. THERE HAVE BEEN NO REPORTED RECURRENCES OF NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS BHCG RESULTS SINCE THE EVENT WAS INITIALLY REPORTED TO OCD.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS BHCG RESULTS FROM MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON THE VITROS3600 IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS BHCG RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, CORRECTED REPORTS WERE SENT TO THE PHYSICIANS AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1