BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 4818749 · Received June 4, 2015

    Report

    Report Number
    1415939-2015-00017
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    May 14, 2015
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ACCURACY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CA125 RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 195.2, REPEAT 124.6 U/ML (36% SHIFT). THE SAMPLE WAS ALSO TESTED ON TWO OTHER METHODS (LIAISON XL AND VITROS) AS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363107 ARCHITECT CA 125 II OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES 46207M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03M74-97 SN (B)(4)| ARCHITECT I2000SR ANALYZER| LN 03M74-97 SN (B)(4)| ARCHITECT I2000SR ANALYZER