BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 20014958 · Received August 21, 2024

    Report

    Report Number
    1823260-2024-02398
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 24, 2024
    Report Date
    April 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    07613336160329
    PMA / PMN Number
    K193313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING. MEDWATCH FIELD E1 FACILITY (B)(6).

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE PRIOR TO THE EVENT. THE PROVIDED DATA SHOWED THAT SOME LEVEL 1 CONTROL RESULTS WERE OUTSIDE OF RANGE. MEASUREMENTS FOR THE IN-USE STABILITY SHOWED VERY GOOD RECOVERY OF CONTROLS AND SAMPLES OVER THE MEASURING RANGE. DURING THE ANALYSIS INTENDED TO ISOLATE CRYSTALS OBSERVED IN THE REAGENT, IT WAS DISCOVERED THAT THERE WERE NO CRYSTALS ACTUALLY PRESENT. WHAT APPEARED TO BE CRYSTALS IN THE REAGENT ARE, IN FACT, TINY AIR BUBBLES. THE TINY BUBBLE-LIKE FORMATIONS ARE DUE TO THE SILICONE SURFACE OF THE BOTTLE INTERACTING WITH THE GLYCERIN IN THE SOLUTION. THE AIR BUBBLES CAN BE EASILY REMOVED BY GENTLY SWAYING THE REAGENT BOTTLE. ALL LYOPHILIZED COMPONENTS OF THE REAGENT DISSOLVE COMPLETELY DURING THE 60 MINUTES OF CONTINUOUS GENTLE AGITATION WITH A ROTATOR, AND THEREFORE THERE IS NO ISSUE. THE NON-REPRODUCIBLE RESULTS CAN BE EXPLAINED BY THE HIGH IMPRECISION IN THE LOWER MEASURING RANGE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER STATED THEY STARTED NOTICING ISSUES WITH THE ELECSYS ANTI-TSHR PRE-TREATMENT REAGENT AS PRECIPITATES/CRYSTALS WERE OBSERVED IN THE WORKING SOLUTION EVEN AFTER 75 MINUTES OF ROTATION ON A ROLLER MIXER. THE ISSUE WAS ALSO NOTICED WITH A SECOND REAGENT LOT (LOT 801939), BUT THERE WAS NO IMPACT ON PATIENT DATA USING THIS LOT. DURING THE USE OF REAGENT LOT 76926902, THE REAGENT PACK HAD TO BE RECALIBRATED SINCE THE FIRST CONTROL LEVEL RECOVERED HIGH. PATIENT SAMPLES RUN BEFORE THE RE-CALIBRATION WERE REPEATED AFTER RE-CALIBRATING. ONE PATIENT SAMPLE HAD DISCREPANT ANTI-TSHR RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE USER REPEATED THE PATIENT SAMPLE SINCE APPROXIMATELY 70 % OF PATIENT SAMPLES USUALLY RESULT IN VALUES OF < 0.8 IU/L. THIS SAMPLE INITIALLY RESULTED IN AN ANTI-TSHR VALUE OF 3.4 IU/L. AFTER RE-CALIBRATION, THE SAMPLE RESULTED IN A VALUE OF 2.5 IU/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372824 ELECSYS ANTI-TSHR THYROID AUTOANTIBODY TEST JZO ROCHE DIAGNOSTICS 76926902 07613336160329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown