BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4663553 · Received April 3, 2015

    Report

    Report Number
    3009351200-2015-00004
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    March 8, 2015
    Report Date
    April 3, 2015
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    142619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ASANTE SOLUTIONS. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED. IF NEW RELEVANY INFO IS DETERMINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A USER OF THE SNAP PUMP REPORTED THREE INSTANCES OF THE "DETACH AND RECONNECT PUMP BODY" ALARM. CHANGING TO A NEW PUMP BODY RESOLVED THE ALARM. AFTER SLEEPING, THE CUSTOMER'S BLOOD GLUCOSE WAS ELEVATED (> 500 MG/DL, WITH LARGE KETONES. THE PUMP WAS NOTED TO BE OFF. PUMP BODY WAS CHANGED AGAIN WITH NO FURTHER ALARMS. A CAREGIVER FAMILIAR WITH DIABETES MANAGEMENT WAS ABLE TO REDUCE THE BLOOD GLUCOSE TO AN ACCEPTABLE LEVEL USING INJECTIONS AND THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221677 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN, 880.5725 LZG ASANTE SOLUTIONS INC. 5501 PP1426004

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening| R