BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15065441 · Received July 20, 2022

    Report

    Report Number
    3004464228-2022-12424
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    July 14, 2022
    Report Date
    July 14, 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

    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 HOSPITALIZATION AND HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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. ADDITIONLLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 POD. 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-000536 TO PT-000435. CATALOG NO CHANGED FROM UNAVAILABLE TO POD-BLE-H1-520. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 550 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. SYMPTOMS REPORTED INCLUDE VOMITING AND THE PRESENCE OF LARGE KETONES. THE PATIENT WAS BEING TREATED WITH AN INSULIN DRIP, INTRAVENOUS FLUIDS AND ANTI-NAUSEA MEDICATION; SHE WAS HOSPITALIZED THE SAME DAY AND REMAINED ADMITTED AT THE TIME OF MEDICAL EVENT REPORTING. THE POD WAS REMOVED ONE HOUR PRIOR TO GOING TO HOSPITAL.; UPON REMOVAL, THE CANNULA WAS FOUND BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181674 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072231
    980713 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072231

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Hospitalization