BEUDAMED
    FDA Adverse Event Other Summary report: N

    INPECO SYSTEM

    MDR report key: 927859 · Received October 15, 2007

    Report

    Report Number
    1628664-2007-00452
    Event Type
    Other
    Date Received
    October 15, 2007
    Report Date
    September 17, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SAMPLE PRESENTATION ERRORS WITH THE INPECO SYSTEM (ACCELERATOR APS). THE CUSTOMER IS CONCERNED REGARDING THE POSSIBILITY OF INCORRECT PATIENT RESULTS BEING REPORTED. THERE IS NO REPORT OF INCORRECT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR