BEUDAMED
    FDA Adverse Event Other Summary report: N

    INPECO SYSTEM

    MDR report key: 930438 · Received October 22, 2007

    Report

    Report Number
    1628664-2007-00461
    Event Type
    Other
    Date Received
    October 22, 2007
    Date of Event
    September 21, 2007
    Report Date
    September 24, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROCESS, NO DETERMINATION CAN BE MADE. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THEY HAD A SAMPLE PRESENTATION ERROR ON THE INPECO SYSTEM. THE ACCOUNT STATED THERE WERE TUBES IN THE WAITING LINE OF ARCHITECT, INSTRUMENT NUMBER 3. THE SCREEN OF THE APS STATED THE INSTRUMENT WENT OFF-LINE, AND AT THAT MOMENT, WHILE THE SAMPLE TAKING TIP WAS PIPETTING THE FIRST TUBE, IT WAS RELEASED BY THE SAMPLING GATE, CONTINUING ASPIRATION OF THE PENDING TESTING IN THE FOLLOWING TUBES. THE OPERATOR WAS UNABLE TO SEE OR IDENTIFY THE AMOUNT OF TUBES INVOLVED. THE FIRST TUBE WAS IDENTIFIED BY THE OPERATOR AND REPEATED. RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    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 YR