BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CEA REAGENT KIT

    MDR report key: 25199795 · Received May 18, 2026

    Report

    Report Number
    3008344661-2026-00073
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHX
    UDI-DI
    00380740159566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). 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 7P62 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P62, 510K K990774. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I CEA RESULTS FOR A 54-YEAR-OLD FEMALE PATIENT 54-YEAR-OLD CLINICALLY DIAGNOSED WITH A MALIGNANT TUMOR OF THE RIGHT BREAST. THE FOLLOWING RESULTS WERE PROVIDED: (REFERENCE RANGE OF <5 NG/ML) SID (B)(6) INITIAL RESULT = 42.11 NG/ML, REPEAT RESULT = 42.05 NG/ML RESULT WITH 1:10 DILUTION = 235.63 NG/ML AND DILUTION RESULT AFTER PEG = 275.39 NG/ML, THE CUSTOMER BELIEVES THE RESULT OF 275.39 NG/ML IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256885 ALINITY I CEA REAGENT KIT SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN DHX ABBOTT IRELAND DIAGNOSTICS DIVISION 78060FZ01 00380740159566

    Patients

    Seq Age Sex Outcome Treatment
    1