BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 7727867 · Received July 27, 2018

    Report

    Report Number
    1823260-2018-02317
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    June 29, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    UDI-DI
    04015630899661
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW SAMPLE FROM THE PATIENT WAS COLLECTED ON (B)(6) 2018 AND WAS TESTED AT AN INVESTIGATION SITE. PLEASE REFER TO THE ATTACHMENT FOR THE INVESTIGATION RESULTS. THE COBAS E411 USED AT THE INVESTIGATION SITE HAD A SERIAL NUMBER OF (B)(4). THE FOLLOWING LOT INFORMATION APPLIES TO THE COBAS E411 USED AT THE INVESTIGATION SITE: TSH LOT 311038 EXPIRES 30-OCT-2018, FT3 III LOT 277945 EXPIRES 30-SEP-2018, FT4 II LOT 303235 EXPIRES 28-FEB-2019, AND FT4 III LOT 304692 EXPIRES 31-JAN-2019. THE COBAS E602 USED AT THE INVESTIGATION SITE HAD A SERIAL NUMBER OF (B)(4). THE FOLLOWING LOT INFORMATION APPLIES TO THE COBAS E602 USED AT THE INVESTIGATION SITE: TSH LOT 311038 EXPIRES 30-OCT-2018, FT3 III LOT 277945 EXPIRES 30-SEP-2018, FT4 II LOT 303235 EXPIRES 28-FEB-2019, AND FT4 III LOT 304692 EXPIRES 31-JAN-2019. FROM THE DATA PROVIDED AT THE INVESTIGATION SITE, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. AS THERE IS NO PATIENT SAMPLE LEFT FOR INTERFERENCE TESTING OR FURTHER INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. - ATTACHMENT: [INVESTIGATIONQ-222244.PDF]

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS TSH ASSAY, ELECSYS FT4 II ASSAY, AND ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 E 601 MODULE COMPARED TO THE RESULTS FROM AN ABBOTT ARCHITECT. RELEVANT MEDWATCHES HAVE PATIENT IDENTIFIERS OF (B)(6). IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E601 SERIAL NUMBER WAS (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567322 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU 04015630899661

    Patients

    Seq Age Sex Outcome Treatment
    1