BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 10051213 · Received May 13, 2020

    Report

    Report Number
    3004464228-2020-06700
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    January 23, 2020
    Report Date
    April 28, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    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/HOSPITALIZATION] AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: 18320, 18296-ENG-AW REV B 06/18. BLOOD GLUCOSE READINGS: CHAPTER 4 / PAGE 56; WARNINGS: BLOOD GLUCOSE READINGS BELOW 70 MG/DL MAY INDICATE HYPOGLYCEMIA (LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 250 MG/DL MAY INDICATE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER'S SUGGESTIONS FOR TREATMENT. LIVING WITH DIABETES: CHAPTER 13 / PAGE 176; AVOID LOWS, HIGHS, AND DKA: YOU CAN AVOID MOST RISKS RELATED TO USING THE OMNIPOD DASH¿ 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 13 / PAGE 182; 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 BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) AND A HEART ATTACK. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 1200 MG/DL WHILE WEARING THE POD. SYMPTOMS REPORTED INCLUDE VOMITING AND KIDNEY DAMAGE. ONCE AT THE HOSPITAL THE POD WAS REMOVED, AND THE PATIENT WAS TREATED WITH AN INTRAVENOUS DRIP. THE PATIENT WAS PRESCRIBED GABAPENTIN (100 MG X 3 DAILY), LISINOPRIL (20 MG X 1 DAILY) AND ATORVASTATIN (40 MG X 1 DAILY). THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 7-10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515360 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization