BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 5962656 · Received September 20, 2016

    Report

    Report Number
    1823260-2016-01411
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 26, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF FURTHER INVESTIGATION, THE TSH RESULT OF THE CUSTOMER COULD NOT BE CONFIRMED. THE TSH RESULT FROM THE PRELIMINARY INVESTIGATION WAS CONFIRMED. IT WAS RECOMMENDED TO MAKE A SYSTEMATIC CHECK OF THE QUALITY CONTROL VALUES FOR THE TSH PARAMETER AT THE CUSTOMER SITE. AN INTERFERING FACTOR WAS NOT IDENTIFIED IN THE SAMPLE RELATED TO THE FT3 III AND FT4 II RESULTS THE CUSTOMER QUESTIONED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE TSH VALUE GENERATED AT THE CUSTOMER SITE WAS NOT CONFIRMED. NO INTERFERENCE FACTORS WERE IDENTIFIED IN THE PATIENT SAMPLE. A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR INVESTIGATION, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3 III) AND ELECSYS FT4 II ASSAY (FT4II). THE CUSTOMER ASKED FOR THE SAMPLE TO BE INVESTIGATED TO CHECK FOR A POSSIBLE INTERFERENCE. BASED ON THE RESULTS FROM THE INVESTIGATION, THE FT3 III AND FT4 II RESULTS AT THE INVESTIGATION SITE WERE COMPARABLE TO THE CUSTOMER'S COBAS 8000 SYSTEM, HOWEVER; ERRONEOUS ELECSYS TSH ASSAY (TSH) RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S COBAS 8000 SYSTEM AND THE MODULAR PE ANALYZER USED AT THE INVESTIGATION SITE. THE CUSTOMER DID NOT QUESTION THE TSH RESULTS AS THE PATIENT HAS BEEN DIAGNOSED WITH SYNDROME OF INAPPROPRIATE SECRETION OF TSH. THE DATE OF TESTS PERFORMED AT THE CUSTOMER SITE IS NOT KNOWN. IT WAS NOTED THAT THE PATIENT HAD A FEVER WHEN HE ENTERED THE HOSPITAL AND THE RESULTS WERE FROM THE 14TH DAY OF THE PATIENT'S HOSPITAL STAY. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. NO ADVERSE EVENT OCCURRED DUE TO THE DEVICE. THE MODULAR PE ANALYZER SERIAL NUMBER WAS (B)(4). THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 143583 WITH AN EXPIRATION DATE OF 12/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S COBAS 8000 SYSTEM IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616069 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR