BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8821620 · Received July 24, 2019

    Report

    Report Number
    3004464228-2019-06721
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 1, 2019
    Report Date
    July 7, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY DEPLOYED. INSPECTION OF THE DEVICE FOUND NO EVIDENCE THAT WOULD RESULT IN THE CANNULA DISLODGING; A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO OTHER DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN.REMOVE FROM EVENT: IT WAS REPORTED THAT THE BG (BLOOD GLUCOSE) VALUE REACHED OVER 400 MG/DL (HIGH) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. THE PATIENT WAS VOMITING AND HAD KETONES. HE REQUIRED AN EMERGENCY ROOM (ER) VISIT AND THEN ADMISSION THE THE HOSPITAL FOR HYPERGLYCEMIA AND DEHYDRATION. ER SAID THE PATIENT WAS BORDERLINE DKA (DIABETIC KETOACIDOSIS) AND HE WAS ADMITTED FOR OBSERVATION. HE RECEIVED SODIUM CHLORIDE 0.9% AT 75 ML PER HOUR TOTAL OF 1000 UNITS, SODIUM CHLORIDE .9% 250 ML, AND A SINGLE DOSE OF ZOFRAN AT 2 MG/ML FOR NAUSEA AT THE HOSPITAL. HE WAS NOT GIVEN ANY INSULIN DUE TO THE CORRECTION BOLUSES THE MOTHER HAD PREVIOUSLY GIVEN HIM, 2 UNITS WERE GIVEN AT 1:10AM, 1:25 AM GAVE 4 UNITS OF INSULIN. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME BG(MG/DL) BOLUS(U) 1:10 AM 2; 1:24 AM HIGH; 1:25 AM 4; 1:55 AM HIGH. 3036 CANNULA AND 3026 UNINTENDED MOVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BG (BLOOD GLUCOSE) VALUE REACHED OVER 400 MG/DL (HIGH) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. THE PATIENT WAS VOMITING AND HAD KETONES. HE REQUIRED AN EMERGENCY ROOM (ER) VISIT AND THEN ADMISSION THE HOSPITAL FOR HYPERGLYCEMIA AND DEHYDRATION. ER SAID THE PATIENT WAS BORDERLINE DKA (DIABETIC KETOACIDOSIS) AND HE WAS ADMITTED FOR OBSERVATION. HE RECEIVED SODIUM CHLORIDE 0.9% AT 75 ML PER HOUR TOTAL OF 1000 UNITS, SODIUM CHLORIDE .9% 250 ML, AND A SINGLE DOSE OF ZOFRAN AT 2 MG/ML FOR NAUSEA AT THE HOSPITAL. HE WAS NOT GIVEN ANY INSULIN DUE TO THE CORRECTION BOLUSES THE MOTHER HAD PREVIOUSLY GIVEN HIM, 2 UNITS WERE GIVEN AT 1:10AM, 1:25 AM GAVE 4 UNITS OF INSULIN. MOTHER REPORTED THAT THE CANNULA DISLODGED. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME BG(MG/DL) BOLUS(U) 1:10 AM 2; 1:24 AM HIGH; 1:25 AM 4; 1:55 AM HIGH.

    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 HYPERGLYCEMIA/BORDERLINE DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 BG (BLOOD GLUCOSE) VALUE REACHED OVER 400 MG/DL (HIGH) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. THE PATIENT WAS VOMITING AND HAD KETONES. HE REQUIRED AN EMERGENCY ROOM (ER) VISIT AND THEN ADMISSION THE HOSPITAL FOR HYPERGLYCEMIA AND DEHYDRATION. ER SAID THE PATIENT WAS BORDERLINE DKA (DIABETIC KETOACIDOSIS) AND HE WAS ADMITTED FOR OBSERVATION. HE RECEIVED SODIUM CHLORIDE 0.9% AT 75 ML PER HOUR TOTAL OF 1000 UNITS, SODIUM CHLORIDE .9% 250 ML, AND A SINGLE DOSE OF ZOFRAN AT 2 MG/ML FOR NAUSEA AT THE HOSPITAL. HE WAS NOT GIVEN ANY INSULIN DUE TO THE CORRECTION BOLUSES THE MOTHER HAD PREVIOUSLY GIVEN HIM, 2 UNITS WERE GIVEN AT 1:10AM, 1:25 AM GAVE 4 UNITS OF INSULIN. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615180 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44246 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization