BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15673001 · Received October 26, 2022

    Report

    Report Number
    3004464228-2022-20020
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 16, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120057
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(4): CATALOG NO CHANGED FROM UNAVAILABLE TO ZXP425. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. IN ADDITION THE POD FAILED TO ADHERE AND REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572235 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female