BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2860240 · Received November 2, 2012

    Report

    Report Number
    3004464228-2012-00557
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 6, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO DEFECT OR MANUFACTURING DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WAS FOUND. THE CUSTOMER THOUGHT THE CANNULA MAY HAVE DISLODGED FROM THE INSERTION SITE. THIS WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. THIS CONDITION CANNOT BE CONFIRMED OR EXCLUDED THROUGH LABORATORY TESTING. 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," "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," 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 RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT TOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(4) 2012 AT 6:45 AM SHE ACTIVATED THE DEVICE. AT 7:35 AM HER BLOOD GLUCOSE WAS 264 MG/DL AND SHE TOOK A 5.0 UNIT INSULIN BOLUS. AT 8:30 AM HER BG WAS UP TO 455 MG/DL. SHE CORRECTED WITH AN ADDITION 7.0 UNIT BOLUS. SHE DEACTIVATED THE POD AT 9:57 AM BECAUSE SHE WAS FEELING BADLY AND THE ADHESIVE FELT DAMP. SHE FELT THAT THE CANNULA HAD INSERTED CORRECTLY BUT HAD DISLODGED FROM HER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30923

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR