BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8106452 · Received November 27, 2018

    Report

    Report Number
    3004464228-2018-08192
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    August 5, 2018
    Report Date
    November 1, 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). THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN. THE PATIENT WAS RELEASED AFTER 8 HOURS OF MEDICAL INTERVENTION. THE POD WAS REMOVED AND DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947321 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention