BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4339890 · Received December 12, 2014

    Report

    Report Number
    3009351200-2014-00013
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    November 22, 2014
    Report Date
    December 12, 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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AS THERE WAS NO ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER IS A (B)(6) YEAR OLD FEMALE, TYPE 2 DIABETIC PRESCRIBED INSULIN, JANUVIA (100 MG/DAY) AND METFORMIN (1500 MG/DAY), BUT WAS TAKEN OFF METFORMIN BY HER MD AND HAS BEEN ON THE SNAP INSULIN PUMP SYSTEM SINCE (B)(6) 2013. CUSTOMER REPORTED SHE WAS IN THE ER ON (B)(6) 2014 WITH BLOOD GLUCOSE (BG) READINGS OF 536, 450, 488 AND 552 MG/DL AND WAS GIVEN 10 UNITS REGULAR INSULIN IV. AT 8:00 AM THE NEXT MORNING, THE BG WAS 253 MG/DL. CUSTOMER REPORTED BLOOD WORK WAS DRAWN WHEN IN THE HOSPITAL, STATING THAT SHE HAD SYMPTOMS OF SORE THROAT, COUGH, NO FEVER BUT FEELING HOT, FOR THE LAST COUPLE OF DAYS. THESE SYMPTOMS DECREASED LATER THAT DAY. CUSTOMER EXPLAINED SHE HAS HAD BG IN THE 300-400 MG/DL RANGE FOR THE LAST COUPLE OF MONTHS CONSISTENTLY SINCE SHE STOPPED TAKING 1500 MG METFORMIN DAILY. WHILE ON METFORMIN, HER BG'S WERE IN THE NORMAL RANGE WITH HER CURRENT SNAP INSULIN PUMP SETTINGS. SHE FURTHER STATE THAT INSULIN PUMP SETTINGS WERE NEVER REEVALUATED OR ADJUSTED AFTER STOPPING METFORMIN. AN ASANTE REPRESENTATIVE SPOKE WITH THE CUSTOMER AS SHE WAS LEAVING MD OFFICE AND SHE EXPLAINED SHE WS INSTRUCT BY MD TODAY TO INCREASE HER BASAL RATE FROM 50 UNITS/24 HOURS TO 55 UNITS/ 24 HOURS. FURTHERMORE, THE CUSTOMER REPORTED HER MD INSTRUCTED HER TO INCREASE HER 24 HOUR ASAL TOTALS 5 UNITS, EVERY 5 DAYS IF BGS WERE STILL RUNNING HIGH. CUSTOMER LATER EXPLAINS SHE DID NOT CHANGE HER BASAL RATE IN THE PUMP, BUT SIMPLY ADDED 5 UNITS OF INSULIN TO EACH MEAL BOLUS. ALTHOUGH THE CUSTOMER THOUGHT HER BASAL RATE WAS SET TO 50 UNITS/24 HOURS, AN ASANTE REPRESENTATIVE HELPED THE CUSTOMER DETERMINE THAT HER BASAL SETTING WAS ACTUALLY AT 34.2 UNITS/24 HOUR AND WAS THEREFORE SET TOO LOW. SHE WAS ASSISTED WITH CALCULATING A CORRECTION BOLUS AT 1:30 PM, 5:15 PM AND AGAIN AT 10 PM. THE CUSTOMER LATER REPORTED SHE WAS DELIVERING BASAL INSULIN AT A RATE OF 55 UNITS/24 HOURS AS INSTRUCTED BY HER MD. THE CUSTOMER WAS INSTRUCTED BY THE ASANTE REPRESENTATIVE TO RETURN TO MD'S OFFICE FOR FURTHER REVIEW AND ADJUSTMENT OF DIABETES REGIMEN. THE FOLLOWING DAY, THE CUSTOMER REPORTED A BG OF 250 AT 6:45 AM. BY 10 AM HER BG HAD DROPPED TO 198. THE CUSTOMER REPORTED SHE IS VERY HAPPY THA THER ISSUE WER RESOLVED AND THAT HER PUMP AND INFUSION SITES WERE FUNCTIONING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808209 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSIN, INSULIN LZG ASANTE SOLUTIONS INC. 7111C

    Patients

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