BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 2883937 · Received December 21, 2012

    Report

    Report Number
    3007111389-2012-00266
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A DISCORDANT VITROS TSH RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE AND/OR A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, SAMPLE MIX UP CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A DISCORDANT, VITROS TSH RESULT (0.1 VS. AN EXPECTED RESULT =0.4 MIU/L) FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE AFFECTED RESULT WAS REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE SAMPLE WAS QUESTIONED BY THE PHYSICIAN AND REPEAT TESTED FOR VITROS TSH AT AN ALTERNATE SITE. CORRECTED REPORT WAS ISSUED. 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
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4140

    Patients

    Seq Age Sex Outcome Treatment
    1