BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 3904263 · Received July 1, 2014

    Report

    Report Number
    3007111389-2014-00141
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT TWO HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A VITROS FREE THYROID QUALITY CONTROL FLUID WHEN PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE, A VITROS TSH REAGENT AND AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED TWO NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TSH RESULTS OBTAINED FROM A VITROS FREE THYROID (FTC) QUALITY CONTROL FLUID LEVEL I WHEN PROCESSED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. FTC LEVEL 1: 0.261 AND 0.288 MIU/L VERSUS EXPECTED 0.062 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. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384613 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4511

    Patients

    Seq Age Sex Outcome Treatment
    1