BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1350167 · Received March 26, 2009

    Report

    Report Number
    1415939-2009-00521
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 20, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURNED MATERIAL WAS REQUESTED FROM THE CUSTOMER SITE. THE INVESTIGATION INVOLVED USING A KIT OF THE SAME REAGENT LOT, 68652M100 (FILE KIT STORED AT ABBOTT) AND TESTED WITH THE ABBOTT CONTROLS AND THREE LEVELS OF ARCHITECT CA 125 PANELS. THE PANELS ARE MADE FROM DEFIBRINATED HUMAN PLASMA AND EACH LEVEL HAS A KNOWN CA 125 CONCENTRATION. ALL OF THE ABBOTT CONTROLS AND PANELS MET SPECIFICATIONS. THIS DEMONSTRATES THAT THE ASSAY IS CAPABLE OF ACCURATELY DETERMINING KNOWN CONCENTRATIONS OF THE CA 125 ANALYTE IN SAMPLES THAT ARE REPRESENTATIVE OF PATIENT SPECIMENS. A REVIEW WAS ALSO CONDUCTED OF THE CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED AT THIS CUSTOMER'S FACILITY. THE REVIEW OF THIS DATA DID NOT IDENTIFY A TREND THAT WOULD SUGGEST A PROBLEM WITH REAGENT LOT 68652M100. OTHER RECORDS REVIEWED ARE THE FINAL RELEASE TESTING DATA FOR LOT 68652M100 AND THE REPLACEMENT LOT, 69459M100. THE ABBOTT CONTROLS AND INTERNAL PANELS REPRESENTATIVE OF PATIENT SPECIMENS WERE WITHIN INTERNAL SPECIFICATIONS. THIS DEMONSTRATES BOTH LOTS WERE DEEMED ACCEPTABLE FOR RELEASE AS PRODUCTS FOR SALE. THE ARCHITECT CA 125 II PACKAGE INSERT (VERSION (B)(4)) PROVIDES ADEQUATE LABELING TO ADDRESS THE CUSTOMER'S ISSUE. THE CURRENT INVESTIGATION UTILIZING MATERIALS STORED AND MAINTAINED AT ABBOTT LABORATORIES DEMONSTRATED THAT THE ARCHITECT CA 125 II ASSAY IS PERFORMING ACCEPTABLY. NO FURTHER INVESTIGATION IS REQUIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER IS QUESTIONING ONE PATIENT'S RESULTS GENERATED BY THE ARCHITECT CA 125 ASSAY. AN INITIAL RESULT OF 96 U/ML WAS GENERATED WITH REAGENT LOT 68652M100 THAT RETESTED AT 16.7 U/ML WITH REAGENT LOT 69459M100. THE SAMPLE WAS RETESTED TWO MORE TIMES WITH LOT 69459M100 AND GENERATED RESULTS OF 29.0 AND 19.4 U/ML. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE REVIEWED THE ARCHITECT I2000SR ANALYZER'S INSTRUMENT LOGS AND FOUND NO INSTRUMENT ISSUES. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II FOR THE DETERMINATION OF OC 125 DEFINED ANTIGEN IN HUMAN SERUM OR PLASMA LTK ABBOTT LABORATORIES 68652M100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR ANALYZER LN:3M74-01 (B)(4)| ARCH I2000SR ANALYZER LN:3M74-01 (B)(4)