BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 4435838 · Received January 17, 2015

    Report

    Report Number
    3009351200-2015-00001
    Event Type
    Injury
    Date Received
    January 17, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 17, 2015
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF LOW BATTERY ALERT/NO POWER ALARM IN PUMP BODY "A" WAS CONFIRMED BY EVALUATION OF THE RETURNED UNIT. HOWEVER, ASANTE BELIEVES THIS MALFUNCTION DID NOT CONTRIBUTED TO THE CUSTOMER'S ELEVATED BLOOD GLUCOSE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ASANTE PUMP BODY WAS OPENED AND THE CUSTOMER BEGAN ITS USE ON THE MORNING OF (B)(6). SHE CALLED IN TO ASANTE CUSTOMER CARE ON THE MORNING OF (B)(6) TO REPORT A LOW POWER ALERT FOLLOWED BY A NO POWER ALARM AND THE PUMP SHUT OFF. SHE WAS ADVISED TO REPLACE THE PUMP BODY AND INSULIN CARTRIDGE. A NEW PUMP BODY AND INSULIN CARTRIDGE WERE STARTED. MID-DAY ON (B)(6), THE CUSTOMER HAD LUNCH AND HER BLOOD GLUCOSE (BG) LEVEL WAS 168 MG/DL, AT WHICH TIME SHE MADE A CORRECTION BOLUS. SHE REPORTED THAT 2 HOURS LATER, HER BG WAS 400 AND BEGAN TO HAVE SOME ABDOMEN PAINS. ONE HOUR LATER, THE CUSTOMER CALLED HER PHYSICIAN AND HER BG WAS AT 438 MG/DL. THE PHYSICIAN INSTRUCTED HER TO CHANGE HER PUMP, INSULIN CARTRIDGE, INFUSION SET AND CANNULA AND REPORT TO THE HOSPITAL, BY THE TIME CUSTOMER WAS SEEN IN HOSPITAL, HER BG LEVEL WAS DOWN TO 150 MG/DL. LAB WORK PERFORMED AT HOSPITAL CONFIRMED DIABETIC KETOACIDOSIS (DKA). THE ASANTE SNAP PUMP SYSTEM WAS REMOVED BY HOSPITAL STAFF AND REPLACED WITH IV. ON (B)(6) 2014 THE CUSTOMER WAS ASKED TO BEGIN USING HER SNAP PUMP SYSTEM AND SHE HAD BREAKFAST. AT 12:30 PM PT HAD LUNCH. AT 3:00 PM HER BG WAS AT 99 MG/DL AND SHE WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42465 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUISON, INSULIN LZG ASANTE SOLUTIONS INC. 5501 PP1426004

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L| R