BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3970063 · Received April 28, 2014

    Report

    Report Number
    3004464228-2014-00551
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 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 NO PRODUCT DEFECT OR MANUFACTURING DEFICIENCY WAS FOUND. AN AIR BUBBLE, EQUAL TO 10 INSULIN UNITS IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. THIS MOST LIKELY OCCURRED DURING THE FILL PROCESS. USER ERROR IS THEREFORE CONSIDERED TO HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED ON (B)(6) 2014 AT 6:56 AM SHE ACTIVATED A NEW POD. AT 12:19 PM THE POD WAS DEACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253368 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40557

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR