BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 2072878 · Received April 29, 2011

    Report

    Report Number
    3007111389-2011-00042
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED TSH PATIENT RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 SYSTEM. PERFORMANCE TESTING AND REVIEW OF INSTRUMENT DATA DEMONSTRATED THAT THE VITROS 5600 ANALYZER WAS OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION DID NOT DETERMINE A ROOT CAUSE OF THIS EVENT, HOWEVER, THE AFFECTED VITROS TSH REAGENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TSH PATIENT RESULTS FOR MULTIPLE PATIENT SAMPLES WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. 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 WERE NO ALLEGATIONS OF HARM TO PATIENTS 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 IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 2890

    Patients

    Seq Age Sex Outcome Treatment
    1