BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2873949 · Received December 14, 2012

    Report

    Report Number
    1415939-2012-02094
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    December 2, 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

    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 PERFORMED ON CA 19-9 REAGENT LOT 14780M500 AND MET ACCEPTANCE CRITERIA. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALZYER GENERATED A FALSELY ELEVATED CA 19-9XR RESULT FOR ONE PATIENT SAMPLE. THE ARCHTIECT GENERATED AN INITIAL CA 19-9XR RESULT OF 225 U/ML AND REPEAT RESULTS OF 3.5, 4.91 AND 5.22 U/ML. THE FALSELY ELEVATED CA 19-9 RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND 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 14780M500

    Patients

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