BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANTI-TG AB

    MDR report key: 24206836 · Received January 29, 2026

    Report

    Report Number
    1219913-2026-00027
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 29, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.
    Product Code
    JZO
    UDI-DI
    00630414962108
    PMA / PMN Number
    K991094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER PROVIDED SPY FILES, ERROR LOGS, AND MAIN DATA FOR ANALYSIS. ANALYSIS OF THE SPY FILES AND ERROR LOGS SHOWED NO ABNORMALITIES. REVIEW OF THE MAIN DATA CONFIRMED THAT THE MOST RECENT CALIBRATION WAS PERFORMED ON (B)(6) 2025. ALTHOUGH THE CALIBRATION ITSELF APPEARED UNREMARKABLE, THE INSTRUCTIONS FOR USE RECOMMEND PERFORMING AN ADJUSTMENT EVERY TWO WEEKS. SINCE THE MEASUREMENTS TOOK PLACE ON (B)(60 2026, THE ADJUSTMENT WAS OVERDUE. CONTROL PERFORMANCE IN THE MAIN DATA WAS ALSO REVIEWED. ON THE SAMPLE TESTING DATE (JANUARY 14TH), QUALITY CONTROLS (QC) LEVEL 1 RECOVERED IN RANGE. CONTROL LEVEL 2 WAS NOT TESTED ON THE MEASUREMENT DATE. A PAST HISTORY REQUEST INDICATED NO ADDITIONAL TICKETS IN THE PAST TWO YEARS RELATED TO ATG FALSE-NEGATIVE RESULTS FOR LOT 804. THE CAUSE FOR THE FALSE NEGATIVE RESULT COULD NOT BE IDENTIFIED. PRE-ANALYTICAL FACTORS OR HANDLING ISSUES CANNOT BE RULED OUT AS POTENTIAL SOURCES OF THE EVENT. SIEMENS RECOMMENDS ADHERING TO THE ADJUSTMENT INTERVAL OF EVERY TWO WEEKS AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED SIEMENS AND INDICATED THAT A FALSE LOW ANTI-THYROGLOBULIN (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 ATG REAGENT. THE FALSE LOW RESULT WAS REPORTED AND QUESTIONED. THE FOLLOWING DAY, THE SAMPLE WAS RUN FOR ATG IN ANOTHER LABORATORY USING A NON-SIEMENS METHOD AND THE RESULT RECOVERED HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO LOW ATG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271154 IMMULITE 2000 ANTI-TG AB SYSTEM, TEST, THYROID AUTOANTIBODY JZO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD. IMMULITE 2000 ANTI-TG AB 804 00630414962108

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female