BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9988615 · Received April 22, 2020

    Report

    Report Number
    3004464228-2020-05851
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 15, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: ENT450. PT-000002-GBR-ENG-MM-AW REV. 002 11/19. BLOOD GLUCOSE READINGS 4 / PAGE 55. WARNINGS: BLOOD GLUCOSE READINGS BELOW 3.9 MMOL/L MAY INDICATE HYPOGLYCEMIA LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 13.9 MMOL/L MAY INDICATE HYPERGLYCEMIA HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER¿S SUGGESTIONS FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 26 MMOL/L (468 MG/DL) WITH KETONES OF 1.7, WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE LEG. THE POD WAS REMOVED, AND THE CANNULA WAS NOTED TO BE BENT. HYPERGLYCEMIA TREATED WITH MULTIPLE BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450505 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR