BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK

    MDR report key: 1083755 · Received July 24, 2008

    Report

    Report Number
    9680658-2008-00220
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDES THAT SAMPLE TUBE PROCESSING WAS TAKING PLACE OUTSIDE OF THE SAMPLE TUBE MANUFACTURES RECOMMENDATIONS, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY USER ERROR. THERE WAS NO ALLEGATION OF PATIENT HARM, AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A FALSELY ELEVATED VITROS TSH RESULT FOR A PATIENT SAMPLE TESTED ON A VITROS ECIQ ANALYZER. THE RESULT WAS REPORTED. THE PATIENT'S PHYSICIAN QUESTIONED THE RESULT AND UPON REPEAT, THE RESULT WAS WITHIN NORMAL OR EXPECTED RANGE. THERE WAS NO ALLEGATION OF PATIENT HARM OR CHANGES IN TREATMENT BASED ON THE INITIAL RESULT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK IN VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS NA 2160

    Patients

    Seq Age Sex Outcome Treatment
    1