BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 24894923 · Received April 16, 2026

    Report

    Report Number
    3005094123-2026-00178
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740131159
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P48, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K983442. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT ALINITY I TSH RESULTS GENERATED FOR AN 82-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMERS REFERENCE RANGE 0.35 UIU/ML TO 4.94 UIU/ML): SAMPLE ID (B)(6): (B)(6) 2026 INITIAL RESULT IN LITHIUM HEPARIN PLASMA TUBE = 0.14 MIU/L, (B)(6) 2026 REPEAT RESULT = 0.07 MIU/L. SAME PATIENT: (B)(6) 2026 RESULT IN SERUM GEL SEPARATOR TUBE = 0.79 MIU/L, (B)(6) 2026 REPEAT RESULT = 0.83 MIU/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955988 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 82588UD00 00380740131159

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)