BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 3718338 · Received April 1, 2014

    Report

    Report Number
    1415939-2014-00082
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 11, 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). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED PATIENT RESULT, WHILE USING ARCHITECT CA 125 II, LOT 29257M500. REVIEW OF TICKET TRENDING DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. HOWEVER, AN INCREASE WAS IDENTIFIED FOR LIKELY CAUSE LOT 29257M500 RELATED TO PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF ARCHITECT CA 125 II REAGENT LOT 29257M500. 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 125 II 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH CLARIFIED THE ARCHITECT CA125 RESULTS WHICH WERE GENERATED.ON (B)(6) 2014 A RESULT OF 420 NG/ML WAS GENERATED.THE PREVIOUS RESULTS FOR THE PATIENT WERE:(B)(6) 2013: 33 NG/ML;(B)(6) 2013: 71.8 NG/ML.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ELEVATED ARCHITECT CA125 RESULT OF 411.90 U/ML WAS GENERATED. THE SAMPLE WAS RETESTED USING A X2 DILUTION AND A RESULT OF 720.60 U/ML WAS GENERATED. THE PATIENT HAD PREVIOUSLY BEEN TESTED WITH RESULTS OF 37 U/ML AND 60 U/ML. THE SAMPLE WAS SENT TO A REFERENCE LAB WHICH OBTAINED RESULTS OF 395.2 AND 384.5 U/ML. DILUTION LINEARITY TESTING SHOWED POOR DILUTION LINEARITY. TESTING PERFORMED WITH HETEROPHIL ANTIBODY BLOCKING REAGENT SHOWED A SIGNIFICANT DECREASE (7.1 U/ML). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194775 ARCHITECT CA 125 II OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES 29257M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER 3M74-01| SN (B)(4)