BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4151568 · Received October 2, 2014

    Report

    Report Number
    3009351200-2014-00011
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 17, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE CONTROLLER MEMORY LOGS INDICATE THAT THE ASANTE SNAP INSULIN PUMP SYSTEM WAS OPERATING PROPERLY UP TO, AND EVEN WHILE THE CUSTOMER WAS AT THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE (SHE MAY HAVE BEEN DIAGNOSED WITH DKA, BUT THE CUSTOMER DID NOT PROVIDE ANY EVIDENCE OF HOSPITAL OR PROFESSIONAL HEALTHCARE PROVIDER DKA DIAGNOSIS). IT IS POSSIBLE THAT SOME OTHER ISSUE CONTRIBUTED TO AN UNANNOUNCED UNDER-DELIVERY OF INSULIN, SUCH AS AN IMPROPERLY PLACED CANNULA, A LOOSE CANNULA SITE CONNECTION, OR A CANNULA THAT HAS COME OUT OF THE BODY. IN ANY OF THESE CIRCUMSTANCES, THE SNAP PUMP SYSTEM WILL NOT ALARM OR OTHERWISE PROVIDE ANY INDICATION OF INSULIN UNDER-DELIVERY (NO INSULIN PUMP ON THE MARKET CURRENTLY HAS SUCH A CAPABILITY).

    Description of Event or Problem · 1

    ON (B)(6) 2014 CUSTOMER STATED SHE RECEIVED AN INDICATOR THAT INSULIN WAS LOW SO SHE CHANGED THE ASANTE SNAP PUMP BODY. SHE RECEIVED AN ERROR MESSAGE - MESSAGE UNKNOWN. CUSTOMER NOTICED HER BLOOD GLUCOSE (BG) LEVEL RISING, ALTHOUGH NO BG VALUES WERE PROVIDED. SHE WAS HOSPITALIZED ON (B)(6) 2014 FOR DIABETIC KETOACIDOSIS (DKA) AND PUT ON INSULIN SHOTS. CUSTOMER STATES SHE ATTEMPTED TO START USING THE ASANTE SNAP PUMP AGAIN IN THE HOSPITAL HER BG BEGAN TO RISE AGAIN. SHE RETURNED TO INJECTION INSULIN THERAPY. SHE TRIED AGAIN ON (B)(6) 2014 TO USE THE PUMP WHEN SHE WENT HOME BY REPLACING THE PUMP BODY, BUT STATES HER BG BEGAN TO RISE AGAIN. CUSTOMER SAYS SHE PRIMED AND DID SEE INSULIN COME OUT OF THE INFUSION SET CONNECTOR NEEDLE. SHE STATES SHE CHANGED THE INJECTION SITE SEVERAL TIMES AS WELL. ON (B)(4) 2014, SHE ATTACHED THE PUMP BODY TO THE CONTROLLER AND GOT A PUMP ERROR-DETACH AND RECONNECT ALARM. CUSTOMER TRIED TO DETACH AND RECONNECT AS WELL AS A NEW "OUT OF BOX" PUMP BODY BUT ISSUE CONTINUED. CUSTOMER IS NOT COMFORTABLE WITH USING THE PUMP. REPLACING PUMP BODIES AND CONTROLLER AND REQUESTED ALL PROBLEM PRODUCTS TO BE RETURNED TO ASANTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615540 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R