BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 3817805 · Received May 19, 2014

    Report

    Report Number
    1415939-2014-00108
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    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). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED PATIENT RESULT, WHILE USING ARCHITECT CA 125 II, LOT 29257M500. REVIEW OF TICKET TRENDING DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY RELATED TO FALSELY ELEVATED RESULTS. THE LOT SEARCH DID IDENTIFY ATYPICAL COMPLAINT ACTIVITY RELATED TO PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF ARCHITECT CA 19-9 REAGENT LOT 29274M500. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. ADDITIONALLY, AN ANALYSIS UTILIZING FIELD DATA WAS COMPLETED TO DETERMINE IF THE MEDIAN PATIENT VALUES HAVE SHIFTED OVER TIME. THE ANALYSIS SHOWED THAT THE MEDIAN VALUE HAS NOT CHANGED OVER TIME AND CONCLUDED THAT THE REAGENT LOTS INCLUDED IN THE ANALYSIS (INCLUDING THE LOT UNDER INVESTIGATION) READ PATIENT RESULTS CONSISTENTLY. THE ARCHITECT CA 19-9 REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT (B)(4) ANALYZER GENERATED FALSELY ELEVATED CA 125 RESULTS FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL CA 125 RESULT OF 84.9 U/ML WHEN CA 125 REAGENT LOT 29257M500 WAS IN USE. THE ANALYZER GENERATED A CA 125 RESULT OF 20.3 U/ML WHEN DILUTED 1:5 MANUALLY, AND A CA 125 RESULT OF 93.1 U/ML WHEN DILUTED 1:10 BY AUTO DILUTION. THE SAMPLE WAS REPEATED WITH ANOTHER LOT OF REAGENT AND A CA 125 RESULT OF 9.0 U/ML WAS GENERATED. THE FALSELY ELEVATED CA 125 RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295939 ARCHITECT CA 125 II OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES 29257M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03M74-01 SN (B)(4)| ARCHITECT I2000SR ANALYZER| LN 03M74-01 SN (B)(4)| ARCHITECT I2000SR ANALYZER