BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULET CORPORATION

    MDR report key: 19668006 · Received July 2, 2024

    Report

    Report Number
    MW5156978
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 28, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER WEARING AN INSULIN PUMP FOR OVER 10 YEARS AND USING THE SAME TYPE OF INSULIN, I TRIALED A NEW INFUSION SITE LOCATION. TYPICALLY, I PLACE THE "INSULIN" INFUSION SITES ON MY ABDOMEN OR "LOVE HANDLE" AREA. FOR THE FIRST TIME, I TRIED WEARING THE OMNIPOD DASH INFUSION PUMP ON MY ARM AND FILLED THE PUMP, WITH HUMALOG INSULIN AS PER MANUFACTURER'S SPECIFICATIONS (I HAVE TAKEN THIS MEDICATION FOR MANY YEARS, APPROX 20 OF THE 25 I HAVE LIVED WITH DIABETES) INSULIN PUMP AS EXPECTED FOR TWO DAYS AND REMOVED THE DISPOSABLE INSULIN PUMP AFTER APPROX 48 HOURS OF USE. AFTER REMOVING THE INSULIN PUMP, I NOTICED A DEPRESSION BENEATH MY SKIN (LIPODYSTROPHY), WHICH I HAVE NEVER SEEN OR EXPERIENCED BEFORE IN THE NEARLY 20 YEARS I HAVE USED AN INSULIN PUMP AND INSULIN. AS DAYS AND WEEKS PASSED, THE DEPRESSION DID NOT IMPROVE AND CONTINUED TO TAKE ON THE APPEARANCE OF A "DIVOT" IN THE BACK OF MY ARM. THERE HAVE BEEN NO CHANGES TO MY MEDICAL HISTORY DURING THIS TIME. MY BLOOD SUGARS CONTINUE TO ME MANAGED WELL AND ARE STABLE AS CONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477533 INSULET CORPORATION PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PD1U11012331

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other CALCIUM + VITAMIN D | DEXCOM G7 CONTINUOUS GLUCOSE MONITOR| GLUCAGON | HUMALOG INSULIN | INSULIN LISPRO| PRENATAL VITAMIN