BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 13684384 · Received March 7, 2022

    Report

    Report Number
    3004464228-2022-03837
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 1, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE. FOR: OMNI POD INSULIN MANAGEMENT SYSTEM USER GUIDE: MODEL: LZG, 18296-ENG-AW REV B. CHANGING YOUR POD. CHAPTER 3 / PAGE 40. WARNINGS: DO NOT USE A POD IF IT IS PAST THE EXPIRATION DATE ON THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312719 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C07292031 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female