BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 5075405 · Received September 14, 2015

    Report

    Report Number
    1823260-2015-04155
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE CONFIRMED AND A STREPTAVIDIN INTERFERING FACTOR WAS DETECTED. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM COBAS E602 ANALYZER SERIAL NUMBER (B)(4). REFER TO THE MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6) FOR THE OTHER ASSAYS. THYROTROPIN (TSH) =1.32 MU/L. FREE THYROXINE (FT4) =3.1 NG/DL. FREE TRIIODOTHYRONINE (FT3) =0.75 NG/DL. THESE RESULTS WERE REPORTED TO THE DOCTOR. AS THE PATIENT WAS SUSPECTED TO HAVE THYROID ISSUES, THE DOCTOR SUSPECTED THE TSH RESULT TO BE INCORRECT AND REQUESTED RETESTING IN A DIFFERENT LAB WITH A SIEMENS VISTA ANALYZER. TSH =2.2 MU/L. FT4 =1.1 NG/DL. FT3 =2.82 PG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606699 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1