BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 24647651 · Received March 20, 2026

    Report

    Report Number
    3005094123-2026-00135
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740162061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P48-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P48, 510K K983442. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I TSH RESULTS FOR A 59-YEAR-OLD FEMALE PATIENT. (CUSTOMER PROVIDED REFERENCE RANGE: 0.35-4.94 U/ML) INITIAL RESULT = 4.4 IU/ML (NEGATIVE), REPEAT RESULT = 4.4 IU/ML, 1:5 DILUTION RESULT = 10 IU/ML .(POSITIVE), 1:10 DILUTION RESULT = 13 IU/ML (POSITIVE), PEG PRECIPITATION = 0.6 U/ML. AUTOBIO RESULT = 17.191 (POSITIVE), ROCHE RESULT = 19 (POSITIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134552 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 73537UD01 00380740162061

    Patients

    Seq Age Sex Outcome Treatment
    1