BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3102127 · Received April 23, 2013

    Report

    Report Number
    3004464228-2013-00374
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    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 ANY MALFUNCTION OR OTHER PRODUCT CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTED TO HYPERGLYCEMIA. 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 THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED" AND "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE SYMPTOMS SUCH AS BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN USUALLY WITH AN INJECTION OF RAPID - ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY." IT ADVISES, "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE), CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS ON AN AIRPLANE AND DID NOT NOTICE THAT HIS BLOOD GLUCOSE WAS GOING UP, UNTIL HE FELT THE CANNULA "POKING HIM". HE CHECKED HIS BLOOD GLUCOSE, AND IT WAS 400 MG/DL. HE HAD BEEN WEARING THE POD FOR OVER 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174144 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40206

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR