BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 3834411 · Received May 28, 2014

    Report

    Report Number
    3007111389-2014-00113
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS TSH RESULT WAS PREDICTED FROM A QUALITY CONTROL FLUID WHEN PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. A VITROS TSH REAGENT AND AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A HIGHER THAN EXPECTED VITROS TSH RESULT PREDICTED FROM A NON-VITROS QUALITY CONTROL MATERIAL LEVEL I WHEN PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. CONTROL LEVEL 1: 0.548 MIU/L VERSUS EXPECTED 0.411 MIU/L. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF TO OCCUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314297 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4470

    Patients

    Seq Age Sex Outcome Treatment
    1