BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2061094 · Received April 18, 2011

    Report

    Report Number
    1319681-2011-00090
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A HIGHER THAN EXPECTED TSH PATIENT RESULT WAS OBTAINED WHILE USING THE VITROS ECI SYSTEM. PERFORMANCE TESTING AND REVIEW OF INSTRUMENT DATA DEMONSTRATED THAT THE VITROS ECI ANALYZER AND TSH REAGENT WERE OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION DID NOT DETERMINE A ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS TSH PATIENT RESULT FOR A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECI IMMUNODIAGNOSTIC ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO DISCREPANT TSH PATIENT RESULTS WERE REPORTED FROM THE LABORATORY TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO THE PATIENT 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 ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1