BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10543070 · Received September 16, 2020

    Report

    Report Number
    3004464228-2020-14753
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    September 5, 2020
    Report Date
    September 5, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE OBSERVED WITH THE EXPOSED PORTION OF THE SOFT CANNULA AND FLUID WAS OBSERVED PASSING THROUGH SUCCESSFULLY. THE DATA DID NOT SHOW ANY INCREASE IN PULSE WIDTHS THAT WOULD INDICATE AN OCCLUSION FROM A BENT/KINKED CANNULA.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 261 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT REPORTED BG LEVELS REMAINED HIGH DESPITE DELIVERING CORRECTIONS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND PATIENT DRANK A LOT OF WATER. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: BG(MG/DL): 261, 253, 243, 241.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005725 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L71043 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR