BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH, PODS 10-PACK

    MDR report key: 19770327 · Received July 18, 2024

    Report

    Report Number
    3004464228-2024-27229
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 18, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000112
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 EMERGENCY ROOM VISIT AND HYPERGLYCEMIA. WE ARE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 33 MMOL/L (594 MG/DL) AND HAD A HEADACHE WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT WORKS AT A HEALTH CLINIC AND TOOK 12 UNITS OF HUMALOG INSULIN PRIOR TO LEAVING FOR THE HOSPITAL. THE MEDICAL PROFESSIONAL REMOVED THE POD FROM THE INSERTION SITE (LEG) AND NOTED THE POD'S CANNULA WAS FOUND BENT. A URINE TEST AND A BLOOD TEST WAS PERFORMED. AS TREATMENT, THE MEDICAL PROFESSIONAL ADMINISTERED 10 UNITS OF INSULIN AND SALINE FOR TREATMENT,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363690 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 PD1U01182411 20385082000112

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention