BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK

    MDR report key: 4132899 · Received October 1, 2014

    Report

    Report Number
    3007111389-2014-00215
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TSH RESULT OCCURRED ON A SINGLE PATIENT SAMPLE. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HISTORICAL TSH QUALITY CONTROL RESULTS WERE ACCEPTABLE PRIOR TO THE EVENT, INDICATING THE VITROS TSH REAGENT WAS PERFORMING AS INTENDED. AN UNKNOWN SAMPLE INTERFERENT OR AN UNEXPECTED VITROS 5600 SYSTEM PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TSH RESULT FOR A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TSH RESULT OF 16.366 MIU/L VS. AN EXPECTED RESULT OF <0.01 MIU/L. THE PATIENT RESULT WAS REPORTED TO A PHYSICIAN WHO QUESTIONED THE RESULT. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. NO TREATMENT WAS ALTERED AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612802 VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4580

    Patients

    Seq Age Sex Outcome Treatment
    1