BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6103297 · Received November 15, 2016

    Report

    Report Number
    1823260-2016-01779
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 28, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BASED ON INVESTIGATION AND TESTING OF THE PATIENT SAMPLE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. RESULTS GENERATED FROM ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND THE STANDARDIZATION METHODOLOGY USED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE THAT WAS TESTED ON WITH DIFFERENT INSTRUMENTS. THE CUSTOMER USED COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). CONTROLS WERE WITHIN SPECIFICATION FOR ALL TESTS. THE FIELD SERVICE REPRESENTATIVE CHANGED THE FT3 REAGENT CASSETTE, RAN A NEW CALIBRATION, AND RAN CONTROLS FOR ALL THREE ASSAYS. THE PATIENT SAMPLE WAS THEN REPEATED ON (B)(6) 2016. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE ELECSYS TSH ASSAY. REFER TO THE MEDWATCHS WITH PATIENT IDENTIFIERS (B)(6) FOR THE OTHER ASSAYS INVOLVED. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753139 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 143583

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR