BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 25219168 · Received May 19, 2026

    Report

    Report Number
    3002809144-2026-00129
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740130527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I CA 19-9XR FOR A 78-YEAR-OLD FEMALE ONCOLOGY PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL CA 19-9 RESULT= 81.38 U/ML; REPEAT RESULTS= 7.99 U/ML, 10.02 U/ML; REPEAT ON ANOTHER ANALYZER= 10.98 U/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128947 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 85981FP00 00380740130527

    Patients

    Seq Age Sex Outcome Treatment
    1