BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 10472031 · Received August 31, 2020

    Report

    Report Number
    3002809144-2020-00877
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOR ARCHITECT CA 19-9XR (LOT 08021M800) 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 THROUGH ABBOTTLINK WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 08021M800 WAS ANALYZED AND FOUND TO BE WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUES FOR THIS LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CA 19-9XR (LOT 08021M800) ASSAY.

    Additional Manufacturer Narrative · 1

    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 2K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33. PATIENT IDENTIFIER COMPLETE SID: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 19-9 RESULT ON 1 PATIENT. RESULTS PROVIDED: (NORMAL RANGE: 0-37 U/ML): SID (B)(6) (UNKNOWN IF PATIENT HAS PANCREATIC CANCER): 1ST RUN RESULT: 36 U/ML (RESULT GENERATED ON (B)(6) 2020 07:44); 2ND RUN RESULT: 39 U/ML (RESULT GENERATED ON (B)(6) 2020 08:19), REPORTED OUT; 3RD RUN RESULT: 55 U/ML (RESULT GENERATED ON (B)(6) 2020 09:01). PREVIOUS RESULT IN (B)(6) 2020 = 39 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934553 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT GMBH 08021M800

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER LIST 03M74-02| ARCHITECT I2000SR ANALYZER LIST 03M74-02| SERIAL (B)(6)| SERIAL (B)(6)