BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 23051810 · Received September 15, 2025

    Report

    Report Number
    3005094123-2025-00454
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 17, 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
    TC
    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

    THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ALINITY I TSH RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. HISTORICAL PERFORMANCE OF REAGENT LOT 75094UD00 WAS EVALUATED USING WORLDWIDE FIELD DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW ON LOT 75094UD00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTIC¿S COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TSH REAGENT, LOT NUMBER 75094UD00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I THYROID STIMULATING HORMONE (TSH) RESULT FOR ONE PATIENT. THE SAMPLE WAS HIGHER BY ANOTHER METHOD. THE FOLLOWING DATA PROVIDED: SID (B)(6), ALINITY TSH RESULT = 3.01 REFERENCE RANGE = 0.37-4.4 UIU/ML. ROCHE RESULT (OTHER LAB) = 5.2 AND 5.1 REFERENCE RANGE = 0.27-4.2 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I THYROID STIMULATING HORMONE (TSH) RESULT FOR ONE PATIENT. THE SAMPLE WAS HIGHER BY ANOTHER METHOD. THE FOLLOWING DATA PROVIDED: SID (B)(6), ALINITY TSH RESULT = 3.01 REFERENCE RANGE = 0.37-4.4 UIU/ML. ROCHE RESULT (OTHER LAB) = 5.2 AND 5.1 REFERENCE RANGE = 0.27-4.2 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489403 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 75094UD00 00380740131159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)