BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6574737 · Received May 18, 2017

    Report

    Report Number
    1823260-2017-01022
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 20, 2017
    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

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S TSH, FT4 II AND FT3 RESULTS WERE REPRODUCED. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS MOST LIKELY CAUSED THE HIGH FT4 II AND FT3 RESULTS AND THE LOW TSH RESULTS. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING. THE INCIDENCE RATE OF THE IDENTIFIED INTERFERING FACTOR IS MONITORED ON A QUARTERLY BASIS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY (TSH), ELECSYS FT4 II ASSAY (FT4 II) AND ELECSYS FT3 (FT3).THE CUSTOMER PROVIDED THE SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS TSH, FT4 II AND FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S COBAS 6000 E 601 MODULE, AN ARCHITECT ANALYZER, AN E601 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 II ERRONEOUS RESULTS AND MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE TSH REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 212491 WITH AN EXPIRATION DATE OF 09/30/2017. THE SERIAL NUMBER FOR THE CUSTOMER'S E601 MODULE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355651 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1