BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9786812 · Received March 4, 2020

    Report

    Report Number
    3004464228-2020-03203
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 13, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000009
    PMA / PMN Number
    K180045
    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 HYPOGLYCEMIA. 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.  HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE, NO MATTER HOW MILD. IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BLOOD GLUCOSE LEVEL TO CONFIRM.  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

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT REPORTS WHEN PERFORMING A MEAL BOLUS IT WAS NOTICEABLY HIGHER THAN SHE THOUGHT IT SHOULD BE, AFTER THE BOLUS HER BLOOD GLUCOSE WAS BETWEEN 20 MG/DL TO 30 MG/DL. TREATMENT PROVIDED WAS INTRAVENOUS FLUIDS BY THE EMERGENCY MEDICAL TECHNICIAN (EMT) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249701 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18239 10385082000009

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R