BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 25055326 · Received May 1, 2026

    Report

    Report Number
    3002809144-2026-00114
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740130527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P32-21, WITH 510K/PMA/BLA NUMBER K052000.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT = 49.13 U/ML, REPEATS = 8.51 U/ML, 10.07 U/ML, 9.01 U/ML, AND 9.60 U/ML HISTORICAL RESULT WAS AROUND 10 U/ML. THE 9.60 U/ML RESULT WAS REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THE PATIENT WAS DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190625 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 79770FP00 00380740130527

    Patients

    Seq Age Sex Outcome Treatment
    1