BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3970033 · Received April 28, 2014

    Report

    Report Number
    3004464228-2014-00558
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    December 6, 2013
    Report Date
    April 25, 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 PRODUCT 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 MANUFACTURING PROCESS. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POD ALARMED AND WHEN HE CHECKED HIS BLOOD GLUCOSE LEVEL, IT WAS 370 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253435 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40655

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR