BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD-5 G6 PACK 5'S (GEN 5)

    MDR report key: 18300986 · Received December 8, 2023

    Report

    Report Number
    MW5149048
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 1, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5149048 ON 01/02/2024 TO UPDATE THE PROCODE TO QFG AND COMMON NAME.

    Description of Event or Problem · 0

    SOME PODS LEAKING, OTHER NOT SYNCING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772501 OMNIPOD-5 G6 PACK 5'S (GEN 5) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PH1K03142
    2240730 OMNIPOD-5 G6 PACK 5'S (GEN 5) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PH1K03142

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male