BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6175351 · Received December 15, 2016

    Report

    Report Number
    1823260-2016-01963
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 28, 2016
    Report Date
    January 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TWO PATIENT SAMPLES WERE RETURNED TO THE MANUFACTURER FOR TESTING. THE INVESTIGATION REPRODUCED THE CUSTOMER'S RESULTS. INTERFERENCE TESTING WAS PERFORMED. NO INTERFERENCES WERE FOUND. NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 1

    CALIBRATION SIGNALS WERE OK. CONTROL VALUES WERE WITHIN SPECIFICATIONS. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. FACTORS SUCH AS STRESS, CHANGES IN PHYSICAL ACTIVITIES AND CIRCADIAN VARIATIONS CAN CAUSE VARIATIONS IN TSH VALUES TAKEN FROM SAMPLES FROM THE SAME PATIENT IN A SHORT PERIOD OF TIME.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH THE ELECSYS TSH ASSAY ON A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER OF THE ANALYZER WAS NOT PROVIDED. THE FIRST SAMPLE WAS TESTED (B)(6) 2016 WITH A TSH OF 8.06 MU/L; THE REPEAT RESULT WAS 8.06 MU/L. THE SECOND SAMPLE WAS TESTED (B)(6) 2016 WITH A TSH OF 3.04 MU/L; THE REPEAT RESULT WAS 3.04 MU/L. TO THE BEST OF THE CUSTOMER'S KNOWLEDGE, THE PATIENT RECEIVED NO TREATMENT BETWEEN THE TWO SAMPLES. THE CLINICIAN DID NOT AGREE WITH THE DIFFERENCE IN THE RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. PATIENT SAMPLES WERE SENT TO THE MANUFACTURER FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829135 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 185522

    Patients

    Seq Age Sex Outcome Treatment
    1