BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 23755235 · Received December 9, 2025

    Report

    Report Number
    3002809144-2025-00388
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 21, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740130534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CA 19-9XR REAGENT LOT 76656FP00. 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. HISTORICAL PERFORMANCE OF REAGENT LOT 76656FP00 EVALUATED USING WORLDWIDE FIELD DATA FOR THE ALINITY I CA 19-9XR ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIANS WERE WITHIN THE ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I CA 19-9XR REAGENT LOT 76656FP00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. RESULTS PROVIDED: >1200 / AUTODILUTION = 500 U/ML. IT IS UNKNOWN WHETHER THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. RESULTS PROVIDED: >1200 / AUTODILUTION = 500 U/ML. IT IS UNKNOWN WHETHER THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858792 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 76656FP00 00380740130534

    Patients

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