BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3122326 · Received May 21, 2013

    Report

    Report Number
    1415939-2013-00214
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 29, 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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF HISTORICAL DATA, DEVICE HISTORY RECORD REVIEW, A REVIEW OF LABELING, AND ACCURACY TESTING. THE INVESTIGATION INCLUDED REVIEW OF THE SUBMITTED DATA AND PRODUCT HISTORICAL DATA. REVIEW OF THE DATA DID NOT IDENTIFY ANY PRODUCT ISSUE OR ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THIS ISSUE IS LIMITED TO A SINGLE PATIENT. COMPARISON BETWEEN METHODS IS NOT ALLOWED PER PRODUCT LABELING. ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ANALYTE AND MET ALL SPECIFICATIONS. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 EXPERIENCED A FALSELY ELEVATED CA19-9XR RESULT FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE SAMPLE WAS LEFT STANDING 10 MINUTES AND CENTRIFUGED AT 3000 RPM X 5 MINUTES. THE FOLLOWING DATA WAS PROVIDED: INITIAL 231.9 U/ML, RETEST OF ORIGINAL SAMPLE 107.3 U/ML, 9.9 U/ML, 5.9 U/ML. THE SAMPLE WAS RECENTRIFUGED AND THE PIPETTED SAMPLE: 4.84 U/ML AND ORIGINAL SAMPLE: 4.48 U/ML. AFTER FURTHER DISCUSSIONS, THE CUSTOMER BELIEVES THERE IS A HIGH POSSIBILITY THAT THIS PHENOMENON WAS DERIVED FROM THE SPECIMEN (IMPACT OF FIBRIN). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223937 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20318M500

    Patients

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