BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD

    MDR report key: 1842675 · Received September 22, 2010

    Report

    Report Number
    MW5017520
    Event Type
    Other
    Date Received
    September 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE IS A PROBLEM WITH THE INSTRUMENT CONTROL PUMP (PDA), MFR NOTIFIED. PDD IS SHORT CIRCUITING AND PUMP IS RESETTING ITSELF. MFR IS GIVING DIFFERENT REASONS WHEN CALLING ABOUT SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN DEVICE LZG

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other