BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2864766 · Received December 10, 2012

    Report

    Report Number
    1415939-2012-02091
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 27, 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 I1000SR ANALYZER GENERATED A FALSELY ELEVATED CA 19-9XR RESULT FOR ONE PATIENT SAMPLE. TRACKING AND TRENDING IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED ON REAGENT LOT 14780M500 AND MET ACCEPTANCE CRITERIA. 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 I1000SR ANALYZER GENERATED A FALSELY ELEVATED CA 19-9XR RESULT OF 4333 FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RETESTED AT ANOTHER LABORATORY (METHOD UNKNOWN) AND A CA 19-9 RESULT OF 311 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED ON THE ARCHITECT AND GENERATED AN INITIAL RESULT OF >1200, AND 1:2 DILUTION VALUES OF 2857.68 AND 2784.91. 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 ARCHITECT I1000SR LN 01L86-01 SN (B)(4)| ARCH I1000SR LN 01L86-01 SN (B)(4)