BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 2489820 · Received March 13, 2012

    Report

    Report Number
    1415939-2012-00060
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Report Date
    February 23, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF ACCURACY TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ALTHOUGH THE LIKELY CAUSE LOT NUMBER FOR THIS TICKET IS UNKNOWN HISTORICAL ACCURACY TESTING, WHICH WAS PERFORMED USING LOTS 95080M500 AND 01066M500, WAS REVIEWED AS REPRESENTATIVE DATA FOR ARCHITECT CA 125. THREE PANELS OF KNOWN CONCENTRATION WERE TESTED ON ONE ARCHITECT INSTRUMENT AND EACH PANEL REPLICATE WAS WITHIN THE RESPECTIVE ACCEPTANCE RANGES FOR EACH REAGENT LOT. NO NON-STATISTICAL TRENDS WERE IDENTIFIED RELATED TO THIS ISSUE. SINCE THE LOT NUMBER IS UNKNOWN A LOT SEARCH WAS NOT COMPLETED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT CA 125 II ASSAY IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER HAS BEEN GENERATED FALSELY ELEVATED CA 125 RESULTS OVER THE PAST FOUR YEARS. THE ARCHITECT HAD BEEN GENERATING CA 125 RESULTS BETWEEN 90 AND 100 U/ML. THE PATIENT WAS THEN TESTED USING ECLUSYS METHODOLOGY AND A CA 125 RESULT OF 10 U/ML WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II LTK ABBOTT LABORATORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR: LN 03M74-01, SN (B)(4)| ARCH I20000SR: LN 03M74-01, SN (B)(4)