BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3242675 · Received July 23, 2013

    Report

    Report Number
    1415939-2013-00299
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    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 HISTORICAL AND COMPLAINT DATA, A REVIEW OF LABELING, AND ACCURACY TESTING. REVIEW OF THE DATA DID NOT IDENTIFY ANY PRODUCT ISSUE OR ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. ALL ACCURACY TEST RESULTS MET SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, NO MALFUNCTION OR DEFICIENCY WAS IDENTIFIED AND THE ARCHITECT CA 19-9XR, LIST NUMBER 02K91, LOT NUMBER 21130M500 IS PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9 RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS >1,200U/ML, PERFORMED 1:10 DILUTION AND THE RESULT WAS 2,601.0U/ML. PREVIOUS RESULT ISSUED BY ARCHITECT WAS 519.90U/ML (B)(6) 2013. PATIENT HISTORICAL DATA: (B)(6). THE PATIENT IS UNDERGOING STEM CELL THERAPY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343906 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 21130M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03M74-02 SN (B)(4)| ARCHITECT I2000SR ANALYZER