BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 2509931 · Received March 29, 2012

    Report

    Report Number
    1415939-2012-00086
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 18, 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

    NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. ACCURACY TESTING WAS PERFORMED USING IN-HOUSE RETAINED REAGENT LOT 02772M500. THREE PANELS OF KNOWN CONCENTRATIONS WERE TESTED ON ONE ARCHITECT INSTRUMENT AND EACH PANEL REPLICATE WAS WITHIN THEIR RESPECTIVE SPECIFICATION RANGES. THE ASSAY IS PERFORMING AS EXPECTED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CA 125 ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT INVESTIGATION, THE ARCHITECT CA 125 II REAGENT IS PERFORMING AS INTENDED. NO ADDITIONAL ISSUES WERE IDENTIFIED AND NO FURTHER INVESTIGATION IS NEEDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED DISCREPANT RESULTS FOR THE ARCHITECT CA125 ASSAY. A RESULT OF 150 U/ML WAS COMPARED TO RESULTS OF 60 AND 200 U/ML. SUSPECT RESULTS WERE NOT REPORTED OUT AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II LTK ABBOTT LABORATORIES 02772M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000 LN: 3M74-01 SN: (B)(4)| ARCHITECT I2000 ANALYZER 3M74-01 SN (B)(4)