BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASM, OMNIPOD 5, PDM

    MDR report key: 15552381 · Received October 6, 2022

    Report

    Report Number
    3004464228-2022-18684
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 28, 2022
    Report Date
    September 29, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    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 HOSPITALIZATION AND HYPOGLYCEMIA. 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): MODEL NO CHANGED FROM PT-000408 TO PT-000409. 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 UNAVAILABLE TO K203768.

    Additional Manufacturer Narrative · 0

    CUSTOMER IS REPORTING THE CONTROLLER DELIVERED AN UNCOMMANDED 15U BOLUS. A 15U BOLUS WAS OBSERVED IN THE CONTROLLER HISTORY. THE BOLUS CALCULATIONS SHOW ALL 15U WERE CALCULATED FROM A USER ADJUSTMENT ADDED TO A MEAL BOLUS OF 0U. FURTHER INVESTIGATION OF 15U BOLUS IN THE LOG FILES SHOWED THE BOLUS COMMANDS THAT INDICATE THE USER CONFIRMED THE BOLUS. THE LOG FILES SHOW THE CONTROLLER WAS ON THE BOLUS CALCULATOR SCREEN FOR THE CALCULATION AND ADJUSTMENT OF THE 15U BOLUS AND THEN THE USER MOVED ON TO THE BOLUS CONFIRMATION SCREEN AND HIT THE BUTTON TO CONFIRM AND SEND THE BOLUS. INVESTIGATION FOUND NO EVIDENCE OF THE CONTROLLER SENDING AN UNCOMMANDED BOLUS. THE CONTROLLER WAS FOUND TO FUNCTION AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNCONSCIOUS AND WAS TAKEN TO THE EMERGENCY ROOM (ER) WHERE THEY WERE DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES THAT DROPPED TO 32 MG/DL. FOR TREATMENT, THE PATIENT WAS GIVEN A MAGNESIUM DRIP, POTASSIUM TABLETS, A BLOOD THINNER AND DIAGNOSTIC TESTS WERE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236652 ASM, OMNIPOD 5, PDM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000467

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H