BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 9122209 · Received September 26, 2019

    Report

    Report Number
    3002809144-2019-00577
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    July 25, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOR ARCHITECT CA19-9XR (LOT 01023M800) 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 CUSTOMERS OBSERVATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD WIDE DATA THROUGH ABBOTTLINK WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 01023M800 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 CA19-9XR (LOT 01023M800) ASSAY. LOT NUMBER CHANGED FROM UNKNOWN TO 01023M800.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9 RESULTS ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 = 83 U/ML / (B)(6) 2019 = 89 U/ML / (B)(6) 2019 = 17.62 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NOT KNOWN IF PATIENT HAS PANCREATIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916414 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT GERMANY 01023M800

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER LIST 03M74-01| ARCHITECT I2000SR ANALYZER LIST 03M74-01| SERIAL (B)(6)| SERIAL (B)(6)| ARCHITECT I2000SR ANALYZER LIST 03M74-01| SERIAL (B)(4)