BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4755822 · Received May 5, 2015

    Report

    Report Number
    3009351200-2015-00005
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    April 5, 2015
    Report Date
    May 5, 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

    NO INFUSION SET OR CANNULA WAS RETURNED FOR ANALYSIS. REVIEW OF THE CONTROL MODULE HISTORY LOG SHOWS NO PUMP ERRORS ON THE EVENT DATE OF (B)(6) 2015. A REVIEW OF THE MANUFACTURING RECORDS FOR THE PUMP CONFIRMED THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE TO MARKET. REVIEW OF SHIPPING RECORDS CONFIRMED THE RETURNED DEVICE WAS SENT TO THE USER IN (B)(4) 2014. THE ELEVATED BLOOD GLUCOSE LEVEL ATTRIBUTED TO A BENT CANNULA OR PUMP ERROR COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A USER REPORTED AN INCIDENT OF DIABETIC KETOACIDOSIS (DKA) WHICH REQUIRED ADMISSION TO THE HOSPITAL. FOLLOWING A MEAL, AFTER A CHANGE OF PUMP AND INFUSION SET, THE USER NOTICED INCREASED BLOOD GLUCOSE LEVELS. THE USER BEGAN TO EXHIBIT SIGNS OF DKA (VOMITING AND NAUSEA), DELIVERED BOLUSES WITH THE PUMP, AND WAS SUBSEQUENTLY TRANSPORTED TO THE HOSPITAL. THE INITIAL REPORT CITED A BENT CANNULA AS A POSSIBLE CAUSE FOR INSULIN DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293138 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN, 880.5725 LZG ASANTE SOLUTIONS, INC. 7211

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R