BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3971194 · Received July 8, 2014

    Report

    Report Number
    3009351200-2014-00005
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BEFORE STATING ON THE ASANTE SNAP INSULIN PUMP SYSTEM, THE CUSTOMER HAD GLYCOHEMOGLOBIN ALC OF 13 AND BLOOD GLUCOSE (BG) READINGS WERE OVER 500 MG/DL. ONCE SHE STARTED ON THE SNAP PUMP, HER BG LEVELS WENT DOWN AND WERE NEVER OVER 170 MG/DL. ASANTE REPLACED HER CONTROL MODULE ON (B)(6) 2014 DUE TO A DAMAGED LCD SCREEN. SHE THEN CALLED ASANTE CUSTOMER CARE ON (B)(6) 2014 STATING SHE HAD "LOST HER PUMP" AND ASANTE SENT A REPLACEMENT CONTROL MODULE. ON (B)(6) 2014 THE CUSTOMER CONTACTED ASANTE BECAUSE HER BG STARTED TO RISE AND SHE WAS NOT THINKING CLEARLY. SHE ASKED TO SPEAK TO THE PERSON THAT TRAINED HER BECAUSE SHE COULD NOT REMEMBER WHAT HER PUMP SETTING WERE SUPPOSED TO BE AND COULD NOT REMEMBER HOW TO ENTER DATA. AN ASANTE CLINICAL MANAGER ATTEMPTED TO CONTACT THE CUSTOMER A NUMBER OF TIMES ON (B)(6) 2014 BUT DID NOT GET A RESPONSE UNTIL THE FOLLOWING DAY. ON (B)(6) 2014 THE CUSTOMER TOLD THE CLINICAL MANAGER THAT SHE WAS IN THE HOSPITAL DUE TO ELEVATED BG. APPARENTLY, THE CUSTOMER MISTAKENLY THOUGHT HER REPLACEMENT CONTROL MODULE (RECEIVED IN (B)(6)) WAS "PRE-PROGRAMMED" WITH HER SETTINGS. SHE WAITED SEVERAL WEEKS BEFORE CONTACTING ASANTE AND DURING THIS TIME WAS RECEIVING INSULIN ONLY FROM MANUAL BOLUSES BECAUSE HER BASAL INSULIN DELIVERY WAS NOT SET UP. THUS, HER BG WAS STEADILY RISING OVER TIME UNTIL SHE REPORTED TO THE HOSPITAL. DURING THE DISCUSSION, THE CUSTOMER REALIZED THE SNAP SYSTEM COULD NOT HAVE BEEN PRESET AND THAT SHE SHOULD HAVE ATTACHED A USED PUMP BODY TO THE REPLACEMENT CONTROL MODULE TO RESTORE HER SETTINGS (PER THE USER MANUAL AND AS SHE WAS PREVIOUSLY TRAINED). HOWEVER, SHE HAD DISPOSED OF ALL HER USED PUMPS AND THEREFORE COULD NOT EASILY RESTORE HER BASAL INSULIN DELIVERY SETTINGS. THE USER MANUAL FOR THE ASANTE SNAP INSULIN PUMP SYSTEM (AND THE CUSTOMER TRAINING) REQUIRE EACH USER TO KEEP A WRITTEN RECORD OF THEIR BASAL SETTINGS ON A SPECIAL PAGE IN THE USER MANUAL. ADDITIONALLY, THE USER MANUAL AND CUSTOMER TRAINING PROVIDE INSTRUCTIONS FOR RESTORING THEIR PERSONAL SETTINGS FROM A USED PUMP BODY. THE ASANTE CLINICAL MANAGER SCHEDULED A TIME TO RE-TRAIN HER AT HOME. HOWEVER, WHEN THERE WAS NO ANSWER AT HER DOOR OR HER PHONE. THE CUSTOMER FINALLY TELEPHONE THE CLINICAL MANAGER AND STATED SHE WAS IN THE EMERGENCY ROOM AS SHE FELL DOWN THE STAIRS. CAUSE WAS NOT MENTIONED. THE CLINICAL MANAGER SET UP ANOTHER TIME TO MEET THE CUSTOMER FOR RE-TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395599 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R