BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15265077 · Received August 22, 2022

    Report

    Report Number
    3004464228-2022-15055
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    July 24, 2022
    Report Date
    July 26, 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 CONFIRM THE REPORTED BOLUS CALCULATOR ISSUE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    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 K203772 TO K203768. CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 6/16/2022.

    Additional Manufacturer Narrative · 0

    IN THE CASE DESCRIPTION, THE USER REPORTED EXPERIENCING CONSTANT HIGH BH LEVELS. THE CUSTOMER ALSO REPORTS THE IOB IS BEING INCORRECTLY RECORDED AND INSULIN AMOUNTS ARE BEING COUNTED WITHIN THE IOB FOR LONGER THAN THE 2.5 HOURS OF TOTAL INSULIN DURATION. THE LOG FILES WERE SUCCESSFULLY DOWNLOADED FOR INVESTIGATION. INVESTIGATION OF THE PHB FILE FOUND THE CALCULATIONS FOR THE CHANGES IN THE MEAL AND CORRECTION IOB TO BE CORRECT BASED ON THE SIZE OF THE BOLUSES SENT BY THE PDM. THE ALGORITHM, MEAL, AND CORRECTION IOBS WERE OBSERVED TO CHANGE AS EXPECTED BASED ON THE CUSTOMER'S REPORTED TOTAL INSULIN DURATION TIME WITHIN THE PHB AND ADDITIONAL BOLUSES BEING COMMANDED BY THE USER. NO ABNORMALITIES WERE OBSERVED WITHIN THE DOWNLOADED LOG FILES THAT WOULD RESULT IN THE IOB BEING INCORRECTLY CALCULATED. ANALYSIS OF THE PHB FILE FOUND THE SYSTEM TO RESPOND AS EXPECTED TO THE EGV TRENDS SENT BY THE CGM AND THE BOLUSES COMMANDED BY THE USER. NO ISSUES WERE OBSERVED THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 200 MG/DL WHILE WEARING THE POD. THE PATIENT STATED THAT THE PERSONAL DIABETES MANAGER (PDM) WAS DELIVERING AN INCORRECT BOLUS AMOUNT TO THE PATIENT. THEY HAD TO ADD A 40 PERCENT INCREASE TO THE CONTROLLER TO LEVEL OUT THEIR BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772105 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000464
    437398 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000464

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male