BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 1871413 · Received October 15, 2010

    Report

    Report Number
    1628664-2010-00375
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A SAMPLE WAS RUN ON THE ARCHITECT I2000SR ANALYZER USING CA19-9 REAGENT LOT 86574M500 AND A RESULT OF 7.56 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER ((B)(4)) WITH REAGENT LOT 86575M500 AND A RESULT OF 71.87 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED ON THIS ANALYZER WITH THE SAME REAGENT AND A RESULT OF 9.73 U/ML WAS GENERATED. IN ADDITION THE ACCOUNT WAS EXPERIENCING A LACK OF REPRODUCIBILITY WITH THE CONTROLS ON THIS ANALYZER. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR FOR THE DETERMINATION OF CA 19-9 ANTIGEN IN HUMAN SERUM OR PLASMA NIG ABBOTT LABORATORIES 86574M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT: CA19-9 2K91-20, LOT 86574M500