BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7216416 · Received January 24, 2018

    Report

    Report Number
    3004464228-2018-00443
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    December 28, 2017
    Report Date
    December 29, 2017
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    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. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. MYLIFE OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: ENT450. 14518-5C-AW REV E 03/16. USING THE POD 5 / PAGE 42-43. WARNING: 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, WHERE AS MAY INDICATE THE CANNULA HAS DISLODGED. WARNING: BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96. WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE CHAPTER 9, LIVING WITH DIABETES), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER. LIVING WITH DIABETES 9 / PAGE 121. WARNING: IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH. TO AVOID DKA THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4¿6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 16.7 MMOL/L (301 MG/DL) AND THEIR KETONES MEASURED AT 4.7 MMOL/L WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. THE PATIENT WAS TREATED WITH INSULIN, FLUIDS, AND POTASSIUM VIA INTRAVENOUS (IV) ROUTE. THE PATIENT'S BASAL RATE WAS ALSO REDUCED TO 18.25. THE PATIENT'S MOTHER NOTED THE CANNULA HAD DISLODGED FROM THE INFUSION SITE AND CALLED WONDERING IF THE BOLUS SHE ADMINISTERED WOULD STILL DELIVER INSULIN. SHE WAS ADVISED THAT IF THE CANNULA WAS OUT OF THE INFUSION SITE THE BOLUS WOULD NOT DELIVER INSULIN. THE PATIENT'S MOTHER DID APPLY A NEW POD, WHICH SEEMS TO BE WORKING FINE. THE PATIENT'S MOTHER DOES NOT THINK THE POD CAUSED THE HIGH BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60987 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810 L43302

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization