BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3140683 · Received May 31, 2013

    Report

    Report Number
    1415939-2013-00255
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT INFORMATION, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. ACCURACY TESTING OF PANELS OF KNOWN ANALYTE CONCENTRATIONS MET ALL SPECIFICATIONS AND ACCEPTANCE CRITERIA. COMPLAINT INFORMATION REASONABLY SUGGESTS THE ASSAY IS PERFORMING AS INTENDED, AND NO MALFUNCTION OF THE DEVICE OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9 RESULT FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED FROM (B)(6) 2013: SID (B)(6) AT 8:16 FIRST TIME MEASURED 48.93 U/ML, AT 8:59 SECOND TIME MEASURED 10.10, AT 9:35 THIRD TIME MEASURED 11.93 (ALL 3 TIMES SPECIMEN ASPIRATED FROM THE SAME PRIMARY TUBE), NORMAL RANGE IS 0-37 U/ML, THEREFORE, THE FIRST RESULT POSITIVE, SECOND AND THIRD RESULT NEGATIVE. ABBOTT CONTROLS WERE TESTED LOW, MED AND HIGH AND ALL IN RANGE. ABBOTT TECHNICAL SUPPORT VISITED THE CUSTOMER AND CHECKED THE INSTRUMENT PERFORMANCE, VALVE PRESSURE, CLEANED THE PRETRIGGER/TRIGGER MANIFOLD AND THERE WAS NO INSTRUMENT LEAKAGE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241591 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 21121M500

    Patients

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