BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 11020711 · Received December 16, 2020

    Report

    Report Number
    3004464228-2020-19754
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    December 9, 2020
    Report Date
    December 14, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 250 MG/DL WHILE WEARING THE POD. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA AND CONFUSION. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED (TREATMENT UNKNOWN). THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 5 DAYS. THE PATIENT WAS PRESCRIBED CEFUROXIME (500 MG X 2) TO BE TAKEN FOR 7 DAYS, ELIQUIS (5 MG X 1) TO BE TAKEN EVERY 12 HOURS FOR 30 DAYS, PACERONE (200 MG X 1) TO BE TAKEN 2 TIMES A DAY AND METOPROLOL (25 MG X 1) TO BE TAKEN EVERY 12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489236 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L71073 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization