BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6094231 · Received November 10, 2016

    Report

    Report Number
    1823260-2016-01757
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 18, 2016
    Report Date
    December 12, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES (OBTAINED A DAY APART) FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S TSH RESULTS WERE REPRODUCED. NO INTERFERING FACTORS WERE IDENTIFIED. THE INVESTIGATION STATED THAT FACTORS SUCH AS STRESS, CHANGES IN PHYSICAL ACTIVITIES AND CIRCADIAN VARIATIONS CAN CAUSE CHANGES IN TSH RESULTS TAKEN FROM 2 SAMPLES TAKEN FROM THE SAME PATIENT WITHIN A SHORT PERIOD OF TIME. BASED ON THE INFORMATION AVAILABLE, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. NO PRODUCT PROBLEMS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TSH ASSAY (TSH). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TSH RESULT WAS 9.56 UIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2016 AND THE RESULT WAS 9.53 WITH A DATA FLAG. A SECOND SAMPLE WAS OBTAINED ON (B)(6) 2016 AND THE INITIAL TSH RESULT WAS 4.96 UIU/ML WITH A DATA FLAG. THE SECOND SAMPLE WAS REPEATED AND THE RESULT WAS 4.93 UIU/ML WITH A DATA FLAG. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743752 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 16636901

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR