BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2884242 · Received December 21, 2012

    Report

    Report Number
    1415939-2012-02120
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 9, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ACCURACY TESTING WAS COMPLETED AND PASSED AFTER THE CALIBRATOR LOT WAS SWAPPED OUT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY ELEVATED CA 19-9XR RESULT FOR ONE PATIENT SAMPLE WHEN REAGENT LOT 17239M500 WAS IN USE. THE ANALYZER GENERATED INITIAL RESULTS OF 50.77 AND 53.52. WHEN REPEATED WITH REAGENT LOT 18067M500 A CA 19-9XR RESULT OF <2.00 WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 17239M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-01, SN (B)(4)