BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD 5

    MDR report key: 20312255 · Received September 25, 2024

    Report

    Report Number
    MW5160139
    Event Type
    Other
    Date Received
    September 25, 2024
    Date of Event
    September 23, 2024
    Report Date
    September 23, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAME UNIQUE IDENTIFIER FOR OMNIPOD 5 COMPATIBLE WITH DEXCOM G6 ONLY AND OMINIPOD 5 COMPATIBLE WITH DEXCOM G6 AND G7. CUSTOMER REPORTS OMNIPOD 5 BOX NOT COMPATIBLE WITH DEXCOM G7. UPON FURTHER LOOKING INTO PRODUCTS IT WAS REALIZED THAT ALTHOUGH PRODUCTS HAVE THE SAME UNIQUE IDENTIFIER THEY ARE NOT THE SAME PRODUCT, THIS WAS CONFIRMED WITH MANUFACTURER AT 1-800-591-3455. MANUFACTURER SUGGESTED THAT WE CONTACT THE DISTRIBUTION CENTER EACH TIME WE ORDER PRODUCT TO CONFIRM WHICH PRODUCT WE WILL RECEIVE AND IT IS THE PHARMACY¿S RESPONSIBILITY TO DISPENSE APPROPRIATELY ALTHOUGH THE UNIQUE IDENTIFIER USED IS THE SAME FOR BOTH PRODUCTS. THESE PRODUCTS SHOULD NOT HAVE THE SAME UNIQUE IDENTIFIER IF THEY ARE NOT THE SAME PRODUCT (COMPLETELY MAKES BARCODE SCANNING TECHNOLOGY TO REDUCE MEDICATION/DEVICE ERRORS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052911 OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Other DEXCOM G6.| DEXCOM G7.