BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 5750695 · Received June 27, 2016

    Report

    Report Number
    1823260-2016-00816
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 27, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULT FOR ONE PATIENT SAMPLE FROM A COBAS E601 ANALYZER. SAMPLE 1 INITIAL RESULT WAS 30.78 MUI/L. SAMPLE 2 WAS DRAWN FROM THE PATIENT AND TESTED ON (B)(6) 2016 AND THE RESULT WAS 0.915 MUI/L. THE REPEAT RESULT WAS 0.897 MUI/L. THE CUSTOMER THEN RETESTED SAMPLE 1 AND THE RESULTS WERE 0.409 MUI/L AND 0.413 MUI/L. ON (B)(6) 2016, BOTH SAMPLES WERE REPEATED AND THE RESULT FROM SAMPLE 1 WAS 0.417 MUI/L. THE RESULT FROM SAMPLE 2 WAS 0.912 MUI/L. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION AND THE RESULTS WERE FOUND TO BE WITHIN THE REFERENCE RANGE AND MATCHED THE REPEAT RESULTS GENERATED BY THE CUSTOMER. COMPARISON OF THE RESULTS BETWEEN TWO ANALYZERS DID NOT SHOW ANY DIFFERENCES. BASED ON THESE RESULTS, A GENERAL REAGENT ISSUE COULD BE EXCLUDED AND NO PRODUCT PROBLEM COULD BE FOUND. AN INTERFERING FACTOR WAS MOST LIKELY NOT IN THE SAMPLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406329 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 15955703

    Patients

    Seq Age Sex Outcome Treatment
    1