BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6100324 · Received November 14, 2016

    Report

    Report Number
    3004464228-2016-03643
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. THE USER REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE AND APPEARED SMALL. 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 (14421-AW REV H) PROVIDES THE FOLLOWING WARNINGS: PAGE 96 - 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 RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER. PAGE 44 - 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 THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIGH BLOOD GLUCOSE (REPORTED RANGE OF 122-450 MG/DL) AND A FAILURE OF CANNULA INSERTION. CANNULA APPEARS SHORTER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752034 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42416 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR