BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6095675 · Received November 11, 2016

    Report

    Report Number
    1823260-2016-01758
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITS OF MEASURE FOR THE BECKMANN COULTER METHOD WERE MIU/L. INVESTIGATION OF THE PATIENT SAMPLE FOUND AN INTERFERING FACTOR TO THE F(AB')2 FRAGMENT OF THE ASSAY ANTIBODY. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR 1 PATIENT SAMPLE TESTED FOR TSH ON A COBAS 8000 E 602 MODULE, SERIAL NUMBER (B)(4). THE TSH ON THE E602 MODULE WAS > 100 MIU/L. THE SAMPLE WAS REPEATED ON A BECKMANN COULTER ANALYZER WITH A TSH OF 0.17 (UNITS OF MEASURE NOT PROVIDED). IT IS UNKNOWN WHETHER THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER IS UNWILLING TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746852 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR