BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8682500 · Received June 10, 2019

    Report

    Report Number
    3004464228-2019-05070
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 21, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400; 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE: CHAPTER 4 / PAGE 36- WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER. CHECKING YOUR BLOOD GLUCOSE : CHAPTER 4 / PAGE 42- WARNING: BLOOD GLUCOSE READINGS THAT ARE ESPECIALLY LOW OR HIGH CAN INDICATE POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH. LIVING WITH DIABETES: CHAPTER 11 / PAGE 119- AVOID LOWS, HIGHS, AND DKA: YOU CAN AVOID MOST RISKS RELATED TO USING THE OMNIPOD® SYSTEM BY PRACTICING PROPER TECHNIQUES AND BY ACTING PROMPTLY AT THE FIRST SIGN OF HYPOGLYCEMIA, HYPERGLYCEMIA, OR DIABETIC KETOACIDOSIS. THE EASIEST AND MOST RELIABLE WAY TO AVOID THESE CONDITIONS IS TO CHECK YOUR BLOOD GLUCOSE OFTEN. LIVING WITH DIABETES: CHAPTER 11 / PAGE 126- WARNINGS: IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH. IF YOU NEED EMERGENCY ATTENTION, ASK A FRIEND OR FAMILY MEMBER TO TAKE YOU TO THE EMERGENCY ROOM OR CALL AN AMBULANCE. DO NOT DRIVE YOURSELF. 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

    IT WAS REPORTED THAT THE PATIENT HAD GONE TO THE EMERGENCY ROOM (ER) WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AROUND 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ABDOMEN. THE PATIENT SAYS THAT SHE TOOK INSULIN, HER DOCTOR GAVE HER 10 UNITS WHILE IN THE OFFICE FROM AN INSULIN PEN, AND SHE WAS INSTRUCTED TO TAKE IT WITH HER, GO TO THE ER AND TAKE ANOTHER 10 UNITS IN 2 HOURS. THE PATIENT BELIEVED THAT SHE WAS NOT RECEIVING HER BOLUSES OR BASAL. THE POD WAS REMOVED AT THE ER; SHE STATED IT ALARMED, SHE DEACTIVATED IT WITH A PAPERCLIP AND THE POD WAS DISCARDED. THE PATIENT WAS TREATED WITH IV INSULIN AND IV FLUIDS AND WHEN THOSE WERE DISCONTINUED SHE WAS GIVEN A LONG ACTING INSULIN VIA INJECTION. THE PATIENT STATED THAT SHE WAS AT THE HOSPITAL FOR LESS THAN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476754 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR