BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8190770 · Received December 21, 2018

    Report

    Report Number
    3004464228-2018-09017
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 27, 2018
    Report Date
    November 27, 2018
    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 HOSPITALIZATION 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 A PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA), CHRONIC KIDNEY FAILURE AND ACUTE HEART ATTACK. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 900 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS (ARM). SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA VOMITING AND DIARRHEA. PATIENT WAS ALSO HAVING TROUBLE URINATING. A HEART CATHETER WAS PLACED, BLOOD TESTS AND MRI'S WERE DONE. THE PATIENT RECEIVED A CONTINUOUS INSULIN DRIP, SLEEP STUDY AND PULMONARY BREATHING TREATMENT. OXYGEN WAS ALSO ADMINISTERED. THE PATIENT WAS PUT ON AMLODIPINE (15 DAYS WORTH 5MG 2X A DAY), CLOPIDOGREL (PLAVEX) 75MG 1X A DAY FOR 30 DAYS. THE PATIENT WAS IN THE HOSPITAL FOR EITHER EIGHT DAYS OR TEN DAYS, WIFE WAS NOT SURE. SIX OR SEVEN OF THOSE DAYS THE PATIENT WAS IN CARDIAC ICU AND THE REST OF THE DAYS HE WAS STILL IN THE CARDIAC UNIT OF THE HOSPITAL, BUT WAS NOT IN ICU. PATIENT'S WIFE BELIEVES THAT HUMALOG IS WHAT CAUSED THE TRIP TO THE HOSPITAL DUE TO HIGH BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029071 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization