BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15246726 · Received August 17, 2022

    Report

    Report Number
    3004464228-2022-14864
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 3, 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

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED 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): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 01020000-000008457. LOT NUMBER WAS CHANGED FROM UNAVAILABLE TO H000436 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 K203774 TO K203768 CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 5/5/2022.

    Additional Manufacturer Narrative · 0

    B5: FROM: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) VALUES DROPPED TO 26 MG/DL. THE PATIENT WAS GIVEN A BOLUS OF 6.4 UNITS OF INSULIN AND THE CONTROLLER GAVE A UNCOMMENTED BOLUS OF INSULIN DROPPING THEIR BG VALUES WHILE IN AUTOMATED MODE. TO: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) VALUES DROPPED TO 26 MG/DL DUE TO THE CONTROLLER DELIVERING A BOLUS INDEPENDENT OF THE USER. THE BOLUS AMOUNT WAS (B)(4) UNITS OF INSULIN FOR 30 CARBS WITH A BG VALUE AT THE TIME OF THE BOLUS OF 150 MG/DL. THE CONTROLLER WAS IN AUTOMATED MODE AT THE TIME OF THE UN-COMMANDED BOLUS AND THE PATIENT WAS SLEEPING. THE USER WAS NOTIFIED OF THE LOW BGS AT 8:45AM THE NEXT MORNING AND WAS ABLE TO SELF-TREAT TO STABILIZE BG LEVELS.

    Additional Manufacturer Narrative · 0

    IN THE CASE DESCRIPTION, THE USER MENTIONED RECEIVING A 6.4U BOLUS FOR 30G OF CARBS THAT THEY DID NOT PROGRAM. INSPECTION OF THE ANDROID LOG FILES DOWNLOADED FROM THE RETURNED CONTROLLER FOUND THE LOG FILES FROM THE DATE OF OCCURRENCE TO BE OVERWRITTEN DUE TO CONTINUED USE OF THE SYSTEM. INSPECTION OF THE AVAILABLE LOG FILES SHOWED NO EVIDENCE OF ISSUES WITH USE OF THE BOLUS CALCULATOR. INSPECTION OF THE LOGS SHOWED THAT THE USER INTERACTED WITH THE CONTROLLER TO OPEN THE BOLUS CALCULATOR, INTERACTED WITH THE BOLUS CALCULATOR SCREEN TO INPUT CARB VALUES AND CGM/BG VALUES, AND CONFIRMED THE BOLUSES FOR DELIVERY. DURING THE INVESTIGATION, NO EVIDENCE OF AN UNCOMMANDED BOLUS WAS OBSERVED. THE CONTROLLER WAS PAIRED WITH AN UNUSED POD, WHICH WAS PAIRED WITH A CGM TX EMULATOR. NO ISSUES WERE OBSERVED DURING FUNCTIONALITY TESTING. THE BOLUS CALCULATOR WAS ALSO FOUND TO FUNCTION AS INTENDED. THE BOLUS CALCULATOR CORRECTLY CALCULATED AND SUGGESTED BOLUSES BASED ON THE USER'S SETTINGS WHEN CARBS AND CGM VALUES WERE ENTERED. THOUGH NO ISSUES WERE OBSERVED DURING THE INVESTIGATION AND IN THE AVAILABLE LOG FILES, IT COULD NOT BE CONCLUSIVELY DETERMINED THAT THE REPORTED 6.4U BOLUS WAS A COMMANDED BOLUS BASED ON 30G OF CARBS DUE TO THE LOG FILES FROM THE DATE OF OCCURRENCE BEING UNAVAILABLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) VALUES DROPPED TO 26 MG/DL. THE PATIENT WAS GIVEN A BOLUS OF 6.4 UNITS OF INSULIN AND THE CONTROLLER GAVE A UNCOMMENTED BOLUS OF INSULIN DROPPING THEIR BG VALUES WHILE IN AUTOMATED MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) VALUES DROPPED TO 26 MG/DL DUE TO THE CONTROLLER DELIVERING A BOLUS INDEPENDENT OF THE USER. THE BOLUS AMOUNT WAS 6.4 UNITS OF INSULIN FOR 30 CARBS WITH A BG VALUE AT THE TIME OF THE BOLUS OF 150 MG/DL. THE CONTROLLER WAS IN AUTOMATED MODE AT THE TIME OF THE UN-COMMANDED BOLUS AND THE PATIENT WAS SLEEPING. THE USER WAS NOTIFIED OF THE LOW BGS AT 8:45AM THE NEXT MORNING AND WAS ABLE TO SELF-TREAT TO STABILIZE BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278724 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000436
    437397 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000436

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male