BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INFUSION PUMP

    MDR report key: 4001574 · Received July 1, 2014

    Report

    Report Number
    3004464228-2014-00908
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    February 3, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND THE INVESTIGATION FOUND EVIDENCE OF AN INTERNAL LEAK. ITS ROOT CAUSE WAS DETERMINED TO BE A DAMAGED CANNULA. THE DAMAGE APPEARED TO HAVE OCCURRED DURING THE MFG PROCESS. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385131 OMNIPOD INFUSION PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40672

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR