BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 9741430 · Received February 21, 2020

    Report

    Report Number
    3004464228-2020-02332
    Event Type
    Death
    Date Received
    February 21, 2020
    Date of Event
    January 28, 2020
    Report Date
    January 28, 2020
    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 DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LIVING WITH DIABETES CHAPTER 13 / PAGE 172-173. WARNING: KEEP AN EMERGENCY KIT WITH YOU AT ALL TIMES TO QUICKLY RESPOND TO ANY DIABETES EMERGENCY. PREPARE AN EMERGENCY KIT TO KEEP WITH YOU AT ALL TIMES. THE KIT SHOULD INCLUDE: SEVERAL NEW, SEALED PODS. A VIAL OF RAPID-ACTING U-100 INSULIN (SEE "GENERAL WARNINGS" ON PAGE XII FOR INSULINS. CLEARED FOR USE IN THE OMNIPOD DASH¿ SYSTEM). SYRINGES OR PENS FOR INJECTING INSULIN. BLOOD GLUCOSE TEST STRIPS. BLOOD GLUCOSE METER. KETONE TEST STRIPS. LANCING DEVICE AND LANCETS. GLUCOSE TABLETS OR ANOTHER FAST-ACTING SOURCE OF CARBOHYDRATE. ALCOHOL PREP SWABS. INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER ABOUT HOW MUCH INSULIN TO INJECT IF DELIVERY FROM THE POD IS INTERRUPTED. A SIGNED LETTER FROM YOUR HEALTHCARE PROVIDER EXPLAINING THAT YOU NEED TO CARRY INSULIN SUPPLIES AND THE OMNIPOD DASH¿ SYSTEM. PHONE NUMBERS FOR YOUR HEALTHCARE PROVIDER AND/OR PHYSICIAN IN CASE OF AN EMERGENCY. GLUCAGON KIT AND WRITTEN INSTRUCTIONS FOR GIVING AN INJECTION IF YOU ARE UNCONSCIOUS (SEE "AVOID LOWS, HIGHS, AND DKA" ON PAGE 176). 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.

    Description of Event or Problem · 1

    THE SISTER OF A PATIENT REPORTS HER SISTER HAS PASSED AWAY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MORE INFORMATION REGARDING THE MEDICAL EVENT AND NO NEW INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202179 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death