BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 23477881 · Received November 5, 2025

    Report

    Report Number
    3005094123-2025-00557
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740131159
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P48-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P48, WITH 510K NUMBER K983442. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I TSH REAGENT LOT 74235UD00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. THE OVERALL PERFORMANCE OF ALINITY I TSH REAGENTS IN THE FIELD WAS REVIEWED. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE PRODUCT LABELLING PROVIDES APPROPRIATE INFORMATION RELATED TO THE CUSTOMER ISSUE, WHICH ASSISTS THEM IN RESOLVING THEIR ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I TSH REAGENT LOT 74235UD00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A 32-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). ALINITY I TSH RESULT (B)(6) 2025 INITIAL RESULT 4.236 MIU/L, REPEATED 4.05 MIU/L. ROCHE RESULT ON (B)(6) 2025 WAS 96.20 UIU/ML. IQRAA HOSPITAL ROCHE RESULT (B)(6) 2025 = >100.0 UIU/ML BECKMAN COULTER RESULT WAS 101.63 UIU/ML. A NEW SAMPLE WAS OBTAINED, AND THE ALINITY I TSH RESULTS WERE 3.0570 AND 3.0415 MIU/L. OTHER RESULTS PROVIDED: TOTAL T3: 0.69 TOTAL T4: 2.93 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A 32-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). ALINITY I TSH RESULT (B)(6) 2025 INITIAL RESULT 4.236 MIU/L, REPEATED 4.05 MIU/L. ROCHE RESULT ON (B)(6) 2025 WAS 96.20 UIU/ML. (B)(6) HOSPITAL ROCHE RESULT 16OCT2025 = >100.0 UIU/ML. BECKMAN COULTER RESULT WAS 101.63 UIU/ML. A NEW SAMPLE WAS OBTAINED, AND THE ALINITY I TSH RESULTS WERE 3.0570 AND 3.0415 MIU/L. OTHER RESULTS PROVIDED: TOTAL T3: 0.69 TOTAL T4: 2.93 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491551 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 74235UD00 00380740131159

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ALNTY I PROCESSING MODU, 03R65-01,(B)(6)