BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4478424 · Received January 30, 2015

    Report

    Report Number
    3009351200-2015-00002
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    December 31, 2014
    Report Date
    January 30, 2015
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K142619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS MANAGING HER DIABETES USING MULTIPLE DAILY INJECTIONS UNTIL STARTING ON THE ASANTE SNAP INSULIN PUMP SYSTEM ON (B)(6) 2014. LESS THAN A MONTH LATER, SHE CONTACTED ASANTE ON (B)(6) 2015 TO REPORT AN ELEVATED BLOOD GLUCOSE (BG) LEVEL THAT HAD REACHED 400 MG/DL AND WAS CURRENTLY AT 364 MG/DL. SHE FELT NAUSEOUS EARLIER AND TOOK COMPAZINE AT MIDNIGHT ALONG WITH 32 OZ OF WATER OVER TWO HOURS. IN CONSULTATION WITH AN ASANTE CLINICAL MANAGER, THE CUSTOMER CHANGED HER INFUSION SITE CANNULA, VERIFIED DURING PRIMING THAT INSULIN FLOW WAS NOT OBSTRUCTED, AND GAVE HERSELF TWO MANUAL INJECTIONS OF INSULIN (5 UNITS AT 2:15AM AND 3 UNITS AT 3:30AM) AND HER BG DROPPED TO 133 MG/DL BY 11:00AM ON (B)(6) 2015. THE DEVICE MEMORY LOGS WERE REVIEWED WITH THE CUSTOMER. THE LOGS SHOWED THAT ON 4 OCCASIONS ((B)(6) 2014) PRIOR TO HER EVENT, SHE RECEIVED "AUTO OFF" ALARMS. THIS ALARM IS A SAFETY FEATURE THAT WILL STOP INSULIN DELIVERY AFTER A SPECIFIED PERIOD OF TIME (12 HOURS IN THIS CASE) IF NO PUMP BUTTONS ARE PRESSED. THIS MEANS THE CUSTOMER WAS NOT DELIVERING ANY BOLUS INSULIN ON FOUR 12-HOUR OCCASIONS AND WAS RELYING ON BASAL DELIVERY OF 0.6 UNITS OF INSULIN PER HOUR. FAILURE TO ADMINISTER PRE-MEAL OR CORRECTION BOLUS INSULIN AND/OR NO DELIVERY OF BASAL INSULIN WILL MOST LIKELY CONTRIBUTE TO INCREASED BG LEVELS. SUBSEQUENT TO THIS EVENT, THE CUSTOMER WAS RE-INSTRUCTED ON PROPER RECOGNITION OF THE AUTO OFF ALARM FUNCTION AND THE IMPORTANCE OF DELIVERING APPROPRIATE BOLUS INSULIN. SHE WAS INSTRUCTED TO CHECK HER BASAL RATE EVERY TIME HER GLUCOSE BEGINS TO RISE. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION AND WAS NOT HOSPITALIZED. HER PHYSICIAN WAS NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71943 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7113 N

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R