BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3172992 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00520
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD 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 CONTRIBUTE 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" 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 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 ALSO WARNS, "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." NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WOKE UP AT 7:23 AM AND CHECKED HER BLOOD GLUCOSE LEVEL. IT WAS 321 MG/DL. SHE GAVE HERSELF A 2U BOLUS AND THEN RECHECKED HER BLOOD GLUCOSE AT 9:03 AM. THE RESULT WAS 348 MG/DL. SHE REMOVED THE POD AND NOTICED THAT THE CANNULA WAS DISLODGED. SHE STATED THAT THE ADHESIVE WAS NOT WET, BUT SHE KNEW THAT THE CANNULA HAD COME OUT. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239849 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR