BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3835818 · Received May 12, 2014

    Report

    Report Number
    3009351200-2014-00004
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ASANTE SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K122483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AN ASANTE CLINICAL REPRESENTATIVE TO REPORT THAT HE WAS IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS (DKA). HE SENT A TEXT MESSAGE STATING THAT "INSULIN HASN'T WORKED". THE CUSTOMER HAS TYPE I DIABETES MELLITUS THAT WAS PREVIOUSLY TREATED BY MULTIPLE DAILY INJECTIONS UNTIL (B)(6) 2014, WHEN HE WAS TRAINED ON THE ASANTE SNAP INSULIN PUMP SYSTEM AND BEGAN USING THE PUMP. ON (B)(6) 2014, HE REPORTED TO THE HOSPITAL. ON (B)(6) 2014, THE CUSTOMER TEXTED THE ASANTE CLINICAL REPRESENTATIVE THAT HE WOULD "KEEP A CLOSER WATCH ON BG AND MAKE SURE INSULIN IS WORKING". SINCE THAT TIME, HE HAS NOT RETURNED REPEATED FOLLOW-UP CALLS FROM THE ASANTE CLINICAL REPRESENTATIVE. NO OTHER DETAILS ARE AVAILABLE AND IT IS UNKNOWN WETHER THE CUSTOMER, WHO WAS NEW TO INSULIN PUMPS, WAS FOLLOWING HIS TRAINING (OR WHETHER A DEVICE MALFUNCTION OCCURRED OR WHETHER THERE WAS A PROBLEM WITH HIS INSULIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283435 ASANTE SNAP INSULIN PUMP SYSTEM PUMP, INFUSION, INSULIN LZG ASANTE SOLUTIONS INC. 7111C

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R