BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 1820988 · Received August 31, 2010

    Report

    Report Number
    9680658-2010-00037
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TSH RESULT OCCURRED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT AN ANALYZER MALFUNCTION OCCURRED AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE WAS VERIFIED BY PROCESSING CONTROLS AND BY PERFORMING A PRECISION TEST.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TSH RESULT ON A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULT WAS REPORTED TO THE CLINICIAN, AND A CORRECTED REPORT WAS ISSUED. 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 IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 2744

    Patients

    Seq Age Sex Outcome Treatment
    1