BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2896206 · Received December 28, 2012

    Report

    Report Number
    3004464228-2012-00683
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED MALFUNCTION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTABLE CRITERIA. THE OMNIPOD USER GUIDE WARNS "IF YOU ARE EXPERIENCING SYMPTOMS THAT ARE NOT CONSISTENT WITH YOUR BLOOD GLUCOSE READING AND YOU HAVE FOLLOWED ALL INSTRUCTIONS DESCRIBED IN THIS USER GUIDE, CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY," AND ADVISES "YOU SHOULD PERFORM A CONTROL SOLUTION TEST WHEN YOU SUSPECT THAT YOUR METER OR TEST STRIPS ARE NOT WORKING PROPERLY OR WHEN YOU THINK YOUR TEST RESULTS ARE NOT ACCURATE OR IF YOUR TEST RESULTS ARE NOT CONSISTENT WITH HOW YOU FEEL."

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT HER SON'S BLOOD GLUCOSE MEASURED 100 MG/DL USING HER PDM, BUT 384 MG/DL PER AN "ACUTOUCH" METER. HE WAS THROWING UP AND HAD KETONES, SO HE WENT TO THE EMERGENCY ROOM WHERE HIS BG WAS OVER 400 MG/DL AND KETONES WERE LARGE. HE WAS TREATED WITH NAVALOG AND FLUIDS. THE MOTHER STATED THAT "BLOOD TESTING CAME BACK OKAY." THEY WERE ADVISED TO USE MANUAL INJECTIONS UNTIL THEY COULD GET THEIR PDM REPLACED. BY THE TIME OF THE CALL, THE PT WAS AT HOME AND FEELING BETTER. HIS BG SEEMED TO BE IN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L50040

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other