BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4101685 · Received August 28, 2014

    Report

    Report Number
    3009351200-2014-00006
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    May 9, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ASANTE INSULIN PUMP SYSTEM, CONTROL MODULE FG-7111, SERIAL NUMBER (B)(4). CUSTOMER REPORTED TWO INCIDENTS OF DIABETIC KETOACIDOSIS (DKA) WHILE ON THE ASANTE SNAP INSULIN PUMP SYSTEM, ONE OF WHICH REQUIRED A HOSP VISIT. ONLY THE CONTROL MODULE PORTION OF THE ASANTE SNAP INSULIN PUMP SYSTEM WAS RETURNED TO ASANTE FOR ANALYSIS THE CUSTOMER HAD DISPOSED OF THE PUMP BODIES AND INFUSION SETS. THE DEVICE CONTROL MODULE WAS VISUALLY INSPECTED. THERE WAS NO VISIBLE DAMAGE. AFTER DECONTAMINATION, THE FRAM MEMORY FILE FROM THE CONTROL MODULE WAS DOWNLOADED FOR ANALYSIS. THE DATA APPEAR TO SHOW THE CUSTOMER BEGAN USING THIS PARTICULAR CONTROL MODULE ON (B)(6) 2014. WE BELIEVE SHE REPORTED TO THE HOSP ON (B)(6) 2014. THE CONTROL MODULE FRAM DATA SHOW THAT BETWEEN (B)(6) 2014 (THE DATE OF HER HOSP VISIT), THE CUSTOMER GAVE HERSELF NO BOLUSES. FOR ANY USER, THIS ALONE WOULD VERY LIKELY CONTRIBUTE TO ELEVATED BLOOD GLUCOSE LEVELS. FROM (B)(6) 2014 THE DATA SHOW THAT THIS CONTROL MODULE WAS NOT USED, WHICH CORRESPONDS TO THE CUSTOMER REPORT INDICATING THAT HER PHYSICIAN RECOMMENDED SHE GO BACK TO USING HER PREVIOUS PUMP BRAND. SEVERAL INSTANCES OCCURRED WHERE THE PATIENT DETACHED THE PUMP BODY FROM THE CONTROL MODULE, LET THE BATTERIES DIE, AND THEN STARTED THE SYSTEM WITH A NEW PUMP BODY. IT IS UNCLEAR WHY. DURING THESE TIMES, THE PATIENT DID NOT RECEIVE INSULIN, AND THIS AGAIN LIKELY CONTRIBUTED TO HER ELEVATED BLOOD GLUCOSE LEVEL. THE CONTROL MODULE DATA ALSO SHOW THAT THE CUSTOMER HAS A PUMP BODY (USED) THAT WAS INITIALIZED ON ANOTHER CONTROL MODULE, WHICH SHE SUBSEQUENTLY CONNECTED TO THIS CONTROL MODULE, POSSIBLY TO DOWNLOAD HER PUMP BODY SETTINGS. IT IS UNK IF THE SETTINGS IN THIS PARTICULAR PUMP BODY WERE CORRECT. THIS MAY HAVE ALSO CONTRIBUTED TO THE ISSUE OF ELEVATED BLOOD GLUCOSE LEVELS. THE FRAM DATA DOWNLOADED FROM THE RETURNED CONTROL MODULE SHOWED AN UNUSUAL USE PATTERN. THE DATA APPEAR TO SHOW THAT THIS CUSTOMER DID NOT PROPERLY USE THE SYSTEM AS INTENDED OR AS SHE WAS TRAINED. ANY INDIVIDUAL THAT RELIES ON BASAL INSULIN DELIVERY ALONE, WITHOUT APPROPRIATE DELIVERY OF PRE-MEAL BOLUS DELIVERY WILL LIKELY EXPERIENCE AN ELEVATED BLOOD GLUCOSE LEVEL. OVER AN EXTENDED TIME, SUCH AS THE FIVE DAYS REPORTED BY THIS CUSTOMER, DKA COULD RESULT. THE ASANTE CLINICAL MGR IS IN CONTACT WITH THE CUSTOMER AND HER PHYSICIAN. WE INTEND TO RETRAIN THE CUSTOMER BEFORE SHE RESUMES USE OF THE ASANTE SNAP INSULIN PUMP SYSTEM. NO DEVICE MALFUNCTION WAS DETECTED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER SENT AN EMAIL MESSAGE TO AN ASANTE CLINICAL MGR AND MENTIONED THAT SHE HAD TWO INCIDENTS OF DKA BACK IN (B)(6) 2014 WHILE ON THE SNAP PUMP; ONCE OCCURRENCE REQUIRED HOSPITALIZATION (WE BELIEVE THIS OCCURRED (B)(6) 2014). CUSTOMER STATED THAT SHE WAS UNSURE OF THE ROOT CAUSE OF THE PROBLEM. SHE TOOK HER SNAP INSULIN PUMP SYSTEM TO HER PHYSICIAN DURING AN OFFICE VISIT AND "HE WAS BAFFLED AS WELL." THE PHYSICIAN SUGGESTED THAT THE CUSTOMER NOT USE THE ASANTE SNAP PUMP SYSTEM AND GO BACK TO HER PREVIOUS PUMP BRAND. CUSTOMER WAS CONTACTED BY AN ASANTE CLINICAL MGR AND INTENDS TO SEND HER ASANTE CONTROLLER BACK FOR ANALYSIS, BUT DISPOSED OF THE PUMP BODY AND INFUSION SET. THE CUSTOMER USES ABOUT 300 UNITS OF INSULIN EVERY 4 DAYS AND APPARENTLY WAS NOT RECEIVING ANY INSULIN FOR SOME PERIOD OF TIME BECAUSE HER STATED BLOOD GLUCOSE WAS 1200 MG/DL WHEN SHE GOT TO THE HOSP. CUSTOMER STATES THAT HER BG GOT UP TO 300 AND SHE WAITED UNTIL IT REACHED 600 MG/DL TO GO TO THE ER. SHE DID RELATE THAT HER JOB MAKES IT VERY DIFFICULT TO CHANGE HER INSULIN, PUMP BODY, OR INFUSION SET AND THAT THE FIRST INCIDENT OF DKA OCCURRED BECAUSE SHE DID NOT HAVE ANY SUPPLIES WITH HER. CUSTOMER REPORTED HAVING A LOW BATTERY ALERT BUT IT IS NOT CLEAR WHETHER THIS RELATES TO HER HOSPITALIZATION. REFER TO DEVICE EVAL SUMMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526645 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R