BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4751939 · Received May 4, 2015

    Report

    Report Number
    3009351200-2015-00006
    Event Type
    Injury
    Date Received
    May 4, 2015
    Date of Event
    April 10, 2014
    Report Date
    May 4, 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

    INVESTIGATION OF THE EVENT FOUND THE FOLLOWING: A REVIEW OF THE HISTORY LOG OF ASANTE SNAP INSULIN SYSTEM CONFIRMED THERE WERE NO ERRONEOUS BOLUSES OR ISSUES WITH THE PUMP DELIVERY. THE TEMP BASAL RATE IS A FEATURE USED TO MANAGE BLOOD GLUCOSE DURING SHORT-TERM ACTIVITIES OR CONDITIONS. THE ALARM HISTORY SHOWING MULTIPLE TEMP BASAL ALARMS IS AN INDICATION THIS FEATURE WAS ENABLED FOR A PERIOD OF 9 HOURS MINIMUM (FIRST ALARM AT 3 HOURS, SECOND ALARM 6 HOURS FOLLOWING). THIS ALTERNATE BASAL INSULIN DELIVERY RATE MAY INDICATE THE BASAL RATE WAS SET TOO HIGH. POST-EVENT THE USER'S PHYSICIAN ADJUSTED THE BASAL RATE DOWN 20%. THE USER HAD AN OVERLAPPING EFFECT DUE TO HAVING A TREATMENT REGIME OF BOTH THE SNAP INSULIN PUMP, AND INJECTING ADDITIONAL INSULIN USING THE LANTUS PEN. THE USER HAS A HISTORY OF SEVERE HYPOGLYCEMIC EVENTS. THE SAME ASANTE SNAP INSULIN PUMP SYSTEM IS STILL IN USE BY THE CUSTOMER AND FUNCTIONING AS DESIGNED. BASED ON THE ABOVE ANALYSIS, THE EVENT WAS LIKELY DUE TO USER PHYSIOLOGICAL CONDITION AND THE TREATMENT REGIME PRESCRIBED AT THIS TIME.

    Description of Event or Problem · 1

    A USER OF THE SNAP PUMP REPORTED A HYPOGLYCEMIC EPISODE AND WAS ADMITTED TO THE HOSPITAL. AT THE TIME OF THE EVENT, EMS CHECKED THE USER BLOOD GLUCOSE WHICH WAS 44 MG/DL. THE CUSTOMER WAS TAKEN OFF THE PUMP AND THE CANNULA REMOVED FROM THE INFUSION SITE. WHEN TREATED WITH DEXTROSE AT THE EMERGENCY ROOM (ER), THE BLOOD GLUCOSE HAD RAISED TO 60 MG/DL. SUBSEQUENTLY, THE ALARM HISTORY WAS CHECKED ON THE PUMP AND FOUND "TEMP BASAL ALARM" FOLLOWED BY "TIME DATE ALARM", THEN A "TEMP BASAL ALARM". THE PUMP REMAINS IN USE BY THE USER AND FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291945 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN, 880.5725 LZG ASANTE SOLUTIONS, INC 7211

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R