BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 15072400 · Received July 21, 2022

    Report

    Report Number
    3004464228-2022-12521
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    July 9, 2022
    Report Date
    July 10, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 MEDICAL ATTENTION AND 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. "HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755 PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A POD ALARM WHICH LED TO HIGH BLOOD GLUCOSE LEVELS AND MEDICAL ATTENTION BEING DELIVERED IN THE FORM OF THE AIRPORT MEDICAL TEAM DELIVERING AN INJECTION ON-SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199576 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1U10162121 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention