BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4339863 · Received December 12, 2014

    Report

    Report Number
    3009351200-2014-00012
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 12, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SNAP INSULIN PUMP WAS PROPERLY PROGRAMMED FOR BASAL DELIVERY USING THE "BASAL A' PUMP SETTING. HOWEVER, THE CUSTOMER INADVERTENTLY MANAGED TO SELECT AND RUN THE "BASAL B" SETTING THAT WAS NOT PROGRAMMED AND THEREBY DID NOT DELIVER ANY BASAL INSULIN FOR 7 DAYS, RESULTING IN HYPERGLYCEMIA.

    Description of Event or Problem · 1

    AN ASANTE CLINICAL MANAGER CONTACTED THE CUSTOMER, WHO REPORTED THAT HER ASANTE SNAP INSULIN PUMP STOPPED (BUT NOT SHOWED IN ALARM HISTORY). SHE STATED THAT HER BLOOD GLUCOSE (BG) WAS OVER 400 MG/DL AND HAD BEEN HIGH FOR THE LAST SEVERAL DAYS AND UNABLE TO BRING IT DOWN. EARLIER ON (B)(6) AT 7:27 AM, THE CUSTOMER REPORTS A BLOCKED SET ALARM (THIS ALARM IS IN THE ALARM HISTORY). CUSTOMER MASSAGED THE CANNULA SITE AND NO FURTHER ALARM OCCURRED. CUSTOMER IS ALSO WEARING A DEXCOM BG MONITOR. A SECOND ASANTE REPRESENTATIVE REPORTED THAT THE CUSTOMER WAS EXPERIENCING DKA-LIKE SYMPTOMS, BUT DID NOT GO THE HOSPITAL AND WAS NOT DIAGNOSED WITH DKA. SHE HAD A HIGH URINE KETONES WITH NAUSEA AND VOMITING. SHE STATES THAT GLUCOSE IS 273 MG/DL THIS MORNING AND THE NAUSEA AND VOMITING HAS SUBSIDED. CUSTOMER WAS ADVISED BY THE ASANTE REPRESENTATIVE TO INCREASE FLUIDS TO CLEAR KETONE BODIES, RE-HYDRATE, AND RUN A TEMPORARY BASAL OF 113 PERCENT FOR 2 HOURS TO HELP LOWER BLOOD GLUCOSE LEVELS. ASANTE CHECKED ON HER APPROXIMATELY EVERY 2 HOURS UNTIL SHE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808173 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7113B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR