BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH

    MDR report key: 15571181 · Received October 10, 2022

    Report

    Report Number
    1823260-2022-03102
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    August 30, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    UDI-DI
    07613336157633
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THAT THE DISCREPANCY IN THE RESULTS FOR SAMPLE ID 220822-316 WAS CONSISTENT WITH METHODOLOGICAL DIFFERENCES IN THE ASSAYS. THE INVESTIGATION ALSO FOUND THAT THE DISCREPANCY IN THE RESULTS FOR SAMPLE ID 220823-200 WAS CONFIRMED TO BE CAUSED BY AUTOANTIBODY INTERFERENCES. PER PRODUCT LABELING, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH AND ELECSYS FT4 III RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT ON A COBAS 8000 E 801 MODULE, SERIAL NUMBER (B)(4). THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE TSH ASSAY. PLEASE REFER TO MEDWATCH MDR-(B)(4) FOR THE ALLEGED FT4 ASSAY RESULTS. REFER TO THE HIGHLIGHTED SECTIONS OF THE ATTACHMENT "PT74631.PDF" FOR PATIENT RESULTS. THE TWO ALLEGED SAMPLES WERE OBTAINED FROM THE SAME PATIENT ON DIFFERENT DAYS. SAMPLE ID: (B)(6) WAS OBTAINED ON (B)(6) 2022. SAMPLE ID: (B)(6) WAS OBTAINED ON (B)(6) 2022. IT IS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2889619 ELECSYS TSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS TSH ASKU 07613336157633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown