BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA19-9XR

    MDR report key: 23864039 · Received December 22, 2025

    Report

    Report Number
    3002809144-2025-00403
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 17, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740137175
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91 - 39, WITH 510K/PMA/BLA NUMBER K052000.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT CA19-9XR REAGENT, LOT 70451FP00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT CA19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN THE ESTABLISHED LIMITS, INDICATING THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA19-9XR REAGENT, LOT 70451FP00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9XR AND PROVIDED THE FOLLOWING DATA: THE SAMPLE WAS THEN TESTED ON LOT 70451FP00. THE RESULT WAS >1200. 10X DILUTION RESULT WAS 777.5. 5X DILUTION RESULT WAS 831.75. AFTER ADDING NEURAMINIDASE REAGENT, THE RESULT WAS 20.48. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9XR AND PROVIDED THE FOLLOWING DATA: THE SAMPLE WAS THEN TESTED ON LOT 70451FP00. THE RESULT WAS >1200. 10X DILUTION RESULT WAS 777.5. 5X DILUTION RESULT WAS 831.75. AFTER ADDING NEURAMINIDASE REAGENT, THE RESULT WAS 20.48. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445317 ARCHITECT CA19-9XR SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 70451FP00 00380740137175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6)