BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6856048 · Received September 11, 2017

    Report

    Report Number
    1823260-2017-01951
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 21, 2017
    Report Date
    October 6, 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

    THE 2 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION AND TESTED ON A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. ERRONEOUS RESULTS WERE GENERATED FOR TSH, FT4 II AND FT3 III. THE E602 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS EITHER (B)(4). THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE TSH REAGENT LOT NUMBER USED WITH THE E602 MODULE WAS 245088 WITH AN EXPIRATION DATE OF 31-JAN-2018. THE TSH REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 220841 WITH AN EXPIRATION DATE OF 30-NOV-2017. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THERE WAS NOT ENOUGH SAMPLE VOLUME LEFT TO COMPLETE THE INVESTIGATION. THE TSH VALUES FROM BOTH THE ROCHE AND ABBOTT METHODS WERE CONSIDERABLY LOWER THAN THE NORMAL REFERENCE RANGES FOR BOTH ASSAYS. THE CLINICAL PICTURE IS THE SAME. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TSH ASSAY (TSH), ELECSYS FT4 II ASSAY (FT4 II) AND ELECSYS FT3 III (FT3 III) ON A COBAS 8000 E 602 MODULE COMPARED TO THE ARCHITECT METHOD. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II ERRONEOUS RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636482 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1