BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3080742 · Received April 26, 2013

    Report

    Report Number
    1415939-2013-00184
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 20278M500. THE TESTING MET THE ACCEPTANCE CRITERIA. THE ARCHITECT CA 19-9XR REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ELEVATED ARCHITECT CA19-9 RESULT WAS GENERATED. AN INITIAL RESULT OF 23 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED AND A RESULT OF 54 U/ML WAS GENERATED. THE SAMPLE WAS RUN AGAIN AND A RESULT OF 20.4 U/ML WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181007 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20278M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER 1L86-01| SN (B)(4)