BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2993147 · Received March 7, 2013

    Report

    Report Number
    1415939-2013-00095
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 19, 2013
    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). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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 18067M500. 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.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT AN ELEVATED ARCHITECT CA 19-9 RESULT OF 165.44 IU/ML WAS GENERATED. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED AFTER RECENTRIFUGING AND RESULTS OF 5.75 AND 6.03 IU/ML WERE GENERATED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97482 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18067M500

    Patients

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