BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1792264 · Received August 10, 2010

    Report

    Report Number
    1628664-2010-00287
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 THE AXSYM ANALYZER HAS GENERATED FALSE ELEVATED TOTAL PSA RESULTS ON 3 PATIENT SAMPLES. ON PATIENT #2, THE INITIAL RESULT WAS 12.0 NG/ML AND THE RETEST RESULT WAS 6.3 NG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PSA REAGENT: L/N 3C19-20, LOT 86259Q100| TOTAL PSA REAGENT: L/N 3C19-20, LOT 86259Q100