BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3071321 · Received April 22, 2013

    Report

    Report Number
    1415939-2013-00180
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICAL COMPLAINT DATA WAS REVIEWED. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE TICKET REVIEW FOR LOT 20318M500 IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 20318M500. THE TESTING MET ACCEPTANCE CRITERIA. THE CUSTOMER'S ISSUE IS LIMITED TO A SINGLE PATIENT, AND WHEN THE SAMPLE WAS RE-DRAWN THE VALUE WAS LOWER. TROUBLESHOOTING CONSISTED OF THE SAMPLE BEING SENT TO ANOTHER LAB WHICH ALSO GENERATED ELEVATED RESULTS (METHOD UNKNOWN). ACCURACY TESTING WAS COMPLETED USING PANELS AND LOT 20318M500 SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ANALYTE. THE INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ARCHITECT CA 19-9XR RESULTS OF 515 - 633 U/ML WERE GENERATED FOR A FEMALE PATIENT ON MARCH 5, 2013. THE ELEVATED RESULTS WERE REPRODUCED AT A DIFFERENT LABORATORY. THE SAME PATIENT TESTED AT 11 U/ML ON (B)(6) 2013. THE PATIENT IS DIAGNOSED WITH HASHIMOTO'S THYROIDITIS AND GILBERT'S SYNDROME. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171003 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20318M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| LIST 01L86-40, SERIAL (B)(4)| LIST 01L86-40, SERIAL (B)(4)| ARCHITECT I1000SR ANALYZER