BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2823098 · Received November 7, 2012

    Report

    Report Number
    1415939-2012-02069
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 26, 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, A SEARCH FOR SIMILAR COMPLAINTS, ACCURACY TESTING, AND A REVIEW OF LABELING. THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY ELEVATED CA 19-9 RESULT FOR ONE PATIENT SAMPLE. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE TICKET REVIEW FOR THE LIKELY CAUSE LOT IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER REVIEW. ACCURACY TESTING WAS COMPLETED TO EVALUATE REAGENT LOT 14778M500 AND ACCEPTANCE CRITERIA WAS MET. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY ELEVATED CA 19-9 RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED A CA 19-9 RESULT OF 41.6. THE SAMPLE WAS SENT TO A REFERENCE LAB AND A CA 19-9 RESULT OF 20.6 WAS GENERATED (METHOD UNKNOWN). 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 14778M500

    Patients

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