BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 10079210 · Received May 21, 2020

    Report

    Report Number
    3004464228-2020-07510
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 16, 2020
    Report Date
    May 16, 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 REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. 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 HYPOGLYCAEMIA LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 13.9 MMOL/L MAY INDICATE HYPERGLYCAEMIA HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER¿S SUGGESTIONS FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CANNULA DID NOT DEPLOY; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544922 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR