BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA19-9XR REAGENT KIT

    MDR report key: 21318760 · Received February 5, 2025

    Report

    Report Number
    3002809144-2025-00033
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 5, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    UDI-DI
    00380740137175
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33 WITH 510K/PMA/BLA NUMBER K052000. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ARCHITECT CA 19-9XR REAGENT AND DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT CA 19-9XR REAGENT REVIEWED USING FIELD DATA FROM CUSTOMERS. THE REVIEW OF FIELD DATA DETERMINED THE MEDIAN PATIENT RESULTS FOR LOT 69360FP00 WAS WITHIN THE ESTABLISHED LIMITS. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CA 19-9XR REAGENT LOT 69360FP00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA19-9XR AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: SAMPLE ID (B)(6) INITIAL RESULT WAS 188.88 U/ML (REFERENCE RANGE < 37 U/ML). THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF 46.45 U/ML. WHEN REPEATED ON ANOTHER ANALYZER, THE RESULT WAS 46.73 U/ML. AFTER PERFORMING SOME TROUBLESHOOTING, THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER 3 TIMES AND GENERATED RESULTS OF 47.09, 46.76, AND 45.96 U/ML. 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
    1248611 ARCHITECT CA19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 69360FP00 00380740137175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2SR ANLYZR G-RFURB, 03M74-95, (B)(6)