BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6124219 · Received November 23, 2016

    Report

    Report Number
    1823260-2016-01845
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    March 7, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS HAVE DETERMINED THAT THE SAMPLE CONTAINS AN INTERFERENT TO THE STREPTAVIDIN PRESENT IN THE FT3, FT4, AND TSH REAGENTS. THIS LIMITATION IS COVERED IN PRODUCT LABELING. THIS INTERFERING FACTOR MOST LIKELY CAUSED THE FALSELY ELEVATED VALUES OF THE FT4 AND FT3 ASSAYS, AS WELL AS THE FALSELY DECREASED VALUE FOR THE TSH ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE SAMPLES FROM THE SAME PATIENT TESTED FOR THE ELECSYS TSH ASSAY (TSH), ELECSYS FT3 III (FT3), AND THE ELECSYS FT4 II ASSAY (FT4) ON A COBAS 6000 E 601 MODULE (E601). THE RESULTS WERE SAID TO NOT BE CONSISTENT WITH THE CLINICAL PICTURE OF THE PATIENT. THIS MEDWATCH WILL COVER TSH. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3 AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT4. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. EACH SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E601 ANALYZER. THE FIFTH SAMPLE WAS REPEATED ON A SIEMENS VISTA ANALYZER SINCE RESULTS FROM THE E601 ANALYZER WERE SAID TO NOT BE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. THE PHYSICIAN CONSIDERED THE RESULTS FROM THE SIEMENS VISTA ANALYZER TO MORE RELIABLY MATCH THE PATIENT'S CLINICAL PICTURE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE USED E601 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED. THE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774642 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 179019

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR SUMATRIPTAN