BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 6098334 · Received November 13, 2016

    Report

    Report Number
    1415939-2016-00108
    Event Type
    Malfunction
    Date Received
    November 13, 2016
    Report Date
    May 9, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER, NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF TICKET TRENDING DATA FOR THE ARCHITECT CA 125 II ASSAY WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY ADVERSE TRENDS OR NON-STATISTICAL TRENDS THAT INDICATE A PRODUCT ISSUE RELATED TO PATIENT RESULTS. A LOT SEARCH WAS NOT PERFORMED SINCE THE LOT NUMBER IS UNKNOWN. SINCE THE LIKELY CAUSE LOT NUMBER IS UNKNOWN, HISTORIC ACCURACY TESTING WAS REVIEWED. THIS TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 50283M500. THE TESTING MET ACCEPTANCE CRITERIA. LABELING WAS ALSO REVIEWED AND ADEQUATELY ADDRESSES THE COMPLAINT ISSUE. BASED ON THIS EVALUATION, THE ARCHITECT CA125 II ASSAY IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED ARCHITECT CA125 II OF 4.6 U/ML ON A PATIENT WHICH DID NOT MATCH PREVIOUS HISTORY OF AROUND 1900 U/ML. THE SAMPLE WAS REPEATED WITH ARCHITECT CA125 II OF ABOUT 1900 U/ML. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749418 ARCHITECT CA 125 II OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST 03M74-02| SERIAL (B)(4)