BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15074880 · Received July 21, 2022

    Report

    Report Number
    3004464228-2022-12544
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 7, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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 DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED CONTROLLER MALFUNCTION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 CONTROLLER. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 01020000-000005433. MODEL NO CHANGED FROM PT-000408 TO PT-000409. LOT NUMBER WAS CHANGED FROM UNAVAILABLE TO H000435 CATALOG NO CHANGED FROM UNAVAILABLE TO SKT-H001-G-X9. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM K203772 TO K203768.

    Description of Event or Problem · 0

    IT WAS REPORTED BY MOTHER THAT WHEN A BOLUS IS DELIVERED THROUGH THE CONTROLLER, IT CAUSES A BASAL PROGRAM DELIVERY ISSUE (GIVES ONLY .05 UNITS, WHICH IS NOT ENOUGH FOR THE PATIENT) AND A DELAY IN FUTURE BOLUS DELIVERIES. THE PATIENT'S BLOOD GLUCOSE LEVEL RISES TO OVER 250 MG/DL AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719937 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000435
    483351 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000435

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male