BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7778677 · Received August 13, 2018

    Report

    Report Number
    3004464228-2018-05116
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 17, 2018
    Report Date
    July 17, 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 SKIN IRRITATION. 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. CHANGING YOUR POD CHAPTER 3 / PAGE 23: WARNINGS: DO NOT USE A POD IF YOU ARE SENSITIVE TO OR HAVE ALLERGIES TO ACRYLIC ADHESIVES, OR HAVE FRAGILE OR EASILY DAMAGED SKIN. IF YOU ARE A FIRST-TIME OMNIPOD SYSTEM USER, YOUR OMNIPOD SYSTEM TRAINER WILL GUIDE YOU THROUGH THE STEPS FOR INITIALIZING AND APPLYING YOUR FIRST POD. DO NOT ATTEMPT TO APPLY OR USE A POD UNTIL YOU HAVE BEEN TRAINED BY YOUR OMNIPOD SYSTEM TRAINER. USE OF THE SYSTEM WITH INADEQUATE TRAINING OR IMPROPER SETUP COULD PUT YOUR HEALTH AND SAFETY AT RISK. LIVING WITH DIABETES CHAPTER 11 / PAGE 115. INFUSION SITE CHECKS AT LEA: ST ONCE A DAY, USE THE POD'S VIEWING WINDOW TO INSPECT THE INFUSION SITE. CHECK THE SITE FOR: LEAKAGE OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED. SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE WAS EXPERIENCING SKIN IRRITATION CAUSING ITCHING AND BURNING AFTER WEARING THE POD FOR 4 TO 24 HOURS. AFTERWARDS, THE PATIENT WOULD DEVELOP A BLISTER. SYMPTOMS BEGAN 24 HOURS INTO USAGE WITH NO EFFECTS TO HER BG LEVELS. THE AFFECTED AREA WAS LOCATED ON THE BACKSIDE OF HER ARM. SHE REPORTED THIS TO HER CDE AND WAS PRESCRIBED ALLERGY CREAMS (NO NAMES GIVEN). SHE MENTIONED THAT SHE HAS SILIAC DISEASE AND DURING THE TRIAL TIME WITH THE PODS SHE WOULD ONLY GET TWO MARKS ON HER SKIN AND SHE WOULD BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619869 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR