BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 5065525 · Received September 9, 2015

    Report

    Report Number
    3007111389-2015-00293
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    June 15, 2015
    Report Date
    September 9, 2015
    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 LOWER THAN EXPECTED TSH QUALITY CONTROL RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS FTC L2 TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, A PRE-ANALYTICAL SAMPLE RELATED ISSUE, AN UNEXPECTED REAGENT OR AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS TSH RESULTS FROM A SINGLE VITROS FREE THYROID CONTROL (FTC) SAMPLE TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM, COMPARED TO THE FTC TARGET MEAN FROM THE PACKAGE INSERT. VITROS FTC L2 RESULTS OF 0.099 AND 0.369 MIU/L VS. AN EXPECTED RESULT OF 1.42 MIU/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE SAME ISSUE OCCURRED UNDETECTED INVOLVING PATIENT SAMPLES. OCD CANNOT CONFIRM THAT PATIENT SAMPLES WERE AFFECTED, AND CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595695 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4750

    Patients

    Seq Age Sex Outcome Treatment
    1