BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 23462233 · Received November 4, 2025

    Report

    Report Number
    3002809144-2025-00350
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740130527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOR ALINITY I CA 19-9XR (LOT 78765FP00) ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD-WIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 78765FP00 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR (LOT 78765FP00) ASSAY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT ON A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS PROVIDED: (B)(6) 2025 SID (B)(6) = >1200 / 1078, X10 DILUTION = 26.2 / 36 U/ML. PREVIOUS RESULT FROM (B)(6) 2025 = 70.5 U/ML. 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. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. RESULTS PROVIDED: ON (B)(6) 2025, SID (B)(6) = >1200 / 1078, X10 DILUTION = 26.2 / 36 U/ML, PREVIOUS RESULT FROM (B)(6) 2025 = 70.5 U/ML , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364688 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 78765FP00 00380740130527

    Patients

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