BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 6853314 · Received September 8, 2017

    Report

    Report Number
    1415939-2017-00178
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Report Date
    October 5, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, IN-HOUSE TESTING AND A REVIEW OF LABELING. REVIEW OF COMPLAINT ACTIVITY DID NOT IDENTIFY ANY ADVERSE OR NON-STATISTICAL TRENDS FOR THE ARCHITECT CA 19-9XR ASSAY. AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR FALSELY ELEVATED OR ERRATIC RESULTS WITH REAGENT LOT 73037M800. ACCURACY TESTING USING RETAINED KITS OF REAGENT LOT 73037M800 WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT. ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT CA 19-9XR ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT CA19-9XR, LIST NUMBER 2K91-32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-29. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT CA19-9XR RESULT. THE EXPECTED RESULT FOR THIS PATIENT WAS 800 U/ML. THE SAMPLE GENERATED THE FOLLOWING RESULTS: SAMPLE ID (B)(6): INITIAL >12000, 1:10 AUTO DILUTION 658.28 U/ML. SAMPLE ID (B)(6) (1:2 DILUTION): 1220.96 U/ML. SAMPLE ID (B)(6) 4 (1:4 DILUTION): 941.55 U/ML. SAMPLE ID (B)(6) 8 (1:8 DILUTION): 829.58 U/ML. SAMPLE ID (B)(6) 16 (1:16 DILUTION): 894.13 U/ML. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631977 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 73037M800

    Patients

    Seq Age Sex Outcome Treatment
    1