BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15139924 · Received August 1, 2022

    Report

    Report Number
    3004464228-2022-13360
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 22, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    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. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(4): EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 11/19/2023. MODEL NO CHANGED FROM PT-000536 TO PT-000435. CATALOG NO CHANGED FROM UNAVAILABLE TO POD-BLE-H1-520. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 5/19/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2937735 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K05192231 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female