BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CA 19-9XR REAGENT KIT

    MDR report key: 23299258 · Received October 15, 2025

    Report

    Report Number
    3002809144-2025-00321
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 20, 2025
    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

    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.

    Additional Manufacturer Narrative · 0

    SECTION B5 WAS UPDATED WITH ADDITIONAL DATA THAT WAS PROVIDED BY THE CUSTOMER ON 20OCT2025. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A TICKET SEARCH FOR COMPLAINT LOT 74583FP00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE ISSUE UNDER REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS FOR COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT NUMBER 74583FP00 WAS EVALUATED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE LOT NUMBERS IN THE FIELD FOR LOT NUMBER 74583FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. A DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA19-9XR ASSAY, LOT 74583FP00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT = 40, REPEAT = 10 INITIAL RESULT = 50, REPEAT = 11 IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL DATA WAS PROVIDED FOR TWO ADDITIONAL SAMPLES THAT WERE IDENTIFIED DURING A REVIEW OF DATA ON INSTRUMENTS (B)(6) AND (B)(6): INITIAL RESULT = 31, REPEAT = 5. INITIAL RESULT = 27, REPEAT = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA19-9XR RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT = 40, REPEAT = 10, INITIAL RESULT = 50, REPEAT = 11, IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. ADDITIONAL DATA WAS PROVIDED FOR TWO ADDITIONAL SAMPLES THAT WERE IDENTIFIED DURING A REVIEW OF DATA ON INSTRUMENTS (B)(6): INITIAL RESULT = 31, REPEAT = 5, INITIAL RESULT = 27, REPEAT = 3. IT IS UNKNOWN IF THE PATIENTS WERE DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020211 ALINITY I CA 19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 74583FP00 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).