BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6054966 · Received October 25, 2016

    Report

    Report Number
    3004464228-2016-03362
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 26, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE AND WAS BENT. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY. VERIFY THAT THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED," "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED," AND "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WAS FOUND.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THEIR BLOOD GLUCOSE LEVEL REACHED 422 MG/DL. THE CANNULA WORKED ITSELF OUT OF THE SKIN AND WAS BENT. THE POD WAS WORN BETWEEN 36 AND 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706153 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42474 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR