BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21108016 · Received January 8, 2025

    Report

    Report Number
    3004464228-2025-01306
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 22, 2024
    Report Date
    January 8, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    Adverse Event
    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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. [1] 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. [1] 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 WAS HOSPITALIZED AT AINTREE UNIVERSITY HOSPITAL DUE TO DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2024. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS "HIGH" (>22.2 MMOL/L,>400 MG/DL) WITH KETONES OF 5.6 WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS ON THE ABDOMEN. SYMPTOM REPORTED INCLUDE HYPERGLYCEMIA. AFTER REPLACING THE POD, THE NEXT POD FELL OFF DUE TO EXCESSIVE SWEATING WHICH PROMPTED THE PATIENT'S MOTHER TO CALL AN AMBULANCE WHERE THE PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT WAS DIAGNOSED WITH DKA, AND TREATED WITH FLUIDS, INSULIN DRIPS AND ANTIBIOTICS. THE PATIENT WAS RELEASED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610977 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1K02292421 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization