BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 7594314 · Received June 12, 2018

    Report

    Report Number
    3007111389-2018-00083
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 12, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED A LOWER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS BECKMAN TSH RESULT. ADDITIONALLY LOWER THAN EXPECTED FSH, LH, PROL AND HIGHER THAN EXPECTED CORT AND TESTOSTERONE (TESTO) RESULTS WERE ALSO OBTAINED FROM THE SAME PATIENT. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS BIOTIN INTERFERENCE. THE PATIENT WAS TAKING A DAILY BIOTIN SUPPLEMENT OF 5.0 MG/DAY. VITROS TSH, FSH, LH, PROL, CORT, OR TESTO ASSAYS ARE SUSCEPTIBLE TO BIOTIN INTERFERENCE. NON-VITROS TSH, PROL, CORT, AND TESTO RESULTS OBTAINED FROM METHODS NOT AFFECTED BY BIOTIN INTERFERENCE GENERATED EXPECTED RESULTS FROM THE PATIENT SAMPLES. IN ADDITION, VITROS FSH, LH, PROL AND TESTO RESULTS WERE CLOSER TO THE EXPECTED RESULTS 2 DAYS AFTER THE PATIENT DISCONTINUED TAKING THE BIOTIN SUPPLEMENTS, WHEN THE BIOTIN WAS STARTING TO CLEAR FROM THE PATIENT'S SYSTEM. ORTHO PREVIOUSLY ISSUED A CUSTOMER LETTER - ¿INFORMATION ON HOW BIOTIN MAY AFFECT SPECIFIC VITROS MICROWELL ASSAYS¿ TO ALERT CUSTOMERS OF THE EFFECT HIGH-DOSE BIOTIN SUPPLEMENTS HAVE ON SOME VITROS IMMUNODIAGNOSTICS PRODUCTS (MICROWELL ASSAYS) SUCH AS THE VITROS TSH, FSH, LH, PROL, CORT, OR TESTO ASSAYS. THESE VITROS ASSAYS INCLUDE THE USE OF STREPTAVIDIN-BIOTIN IN THE DESIGN WHICH MAY BE SUSCEPTIBLE TO BIOTIN INTERFERENCE. THEREFORE, THE BIOTIN IN THE SAMPLES IS A POTENTIAL INTERFERING SUBSTANCE AND CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    AN ARTICLE PUBLISHED IN JOURNAL OF THE ENDOCRINE SOCIETY (JES), A PEER-REVIEWED MEDICAL JOURNAL PUBLISHED MONTHLY BY THE ENDOCRINE SOCIETY. (SUSPECTED TESTOSTERONE-PRODUCING TUMOR IN A PATIENT TAKING BIOTIN SUPPLEMENTS (JES. 2018) DOI/10.1210/JS.2018-00069/4994589) DOCUMENTED A CASE STUDY INVOLVING A (B)(6)-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE ENDOCRINOLOGY CLINIC WITH PALPITATIONS, INABILITY TO LOSE WEIGHT AND HIRSUTISM. THE REFERRING PROVIDER QUESTIONED WHETHER THESE SYMPTOMS MIGHT BE RELATED TO THE PATIENT¿S KNOWN THYROID DYSFUNCTION, SUBCLINICAL HYPERTHYROIDISM, PREVIOUSLY DIAGNOSED. THE PATIENT WAS TAKING A DAILY BIOTIN SUPPLEMENT OF 5.0 MG/DAY. A LOWER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS BECKMAN TSH RESULT WHICH IS NOT SUSCEPTIBLE TO BIOTIN INTERFERENCE. PATIENT SAMPLE VITROS TSH RESULTS OF 0.06 MIU/L VS. THE EXPECTED TSH RESULT OF 1.1 MIU/L BIASED TSH RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ADDITIONALLY, BASED ON LOWER THAN EXPECTED VITROS PROLACTIN (PROL) AND HIGHER THAN EXPECTED VITROS CORTISOL (CORT) RESULTS, THE PATIENT UNDERWENT A CT SCAN AND MRI. BASED ON MEDICAL CONSULTATIONS WITH THE ORTHO MEDICAL SAFETY OFFICER, SERIOUS LONG TERM HEALTH IMPACT FROM THE MRI OR CT PROCEDURES IS NOT ANTICIPATED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM DUE TO THE EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE 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
    436523 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other