BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 12933191 · Received December 6, 2021

    Report

    Report Number
    3004464228-2021-21752
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 30, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    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 AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER WEARING THE POD ON THE ARM BETWEEN 24 AND 36 HOURS, THE SITE WAS PAINFUL AND INFECTED. THE PATIENT VISITED THE EMERGENCY ROOM (ER) WHERE THE SITE WAS CUT OPEN IN 5 CM AND PRESCRIBED ANTIBIOTICS (AMOCLAV 875/125 MG) TO BE TAKEN TWICE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832084 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention