BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASANTE SNAP INSULIN PUMP SYS

    MDR report key: 4135675 · Received September 26, 2014

    Report

    Report Number
    3009351200-2014-00010
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 26, 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

    PT CODE: VOMITING. DEVICE CODE: FAILURE TO INFUSE, USE OF DEVICE ISSUE. METHOD CODE: LABELING EVALUATION (REVIEWING ALL LABELING (INCLUDING INSTRUCTIONS FOR USE, MANUALS, AND PACKAGING) FOR LANGUAGE RELATED TO REPORTED DEVICE PROBLEMS.)) RESULTS CODE: DEFORMATION PROBLEM. CONCLUSION CODE: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT. DEVICE NOT RETURNED. KNOWN INHERENT RISK OF PROCEDURE.

    Description of Event or Problem · 1

    ASANTE TERRITORY SALES MGR INFORMED CUSTOMER SERVICE THAT A (B)(6) YEAR OLD PT WAS IN THE NURSES OFFICE AT SCHOOL WITH A BLOOD GLUCOSE LEVEL OF 600 MG/DL AND WAS VOMITING. THE ISSUE APPEARED TO BE WITH THE CANNULA. THE PT HAD PREVIOUSLY EXPERIENCED THIS SAME ISSUE WHILE USING THE ANIMAS PUMP. ACCORDING TO THE ASANTE CLINICAL MGR WHO TRAINED THIS PT, THE ISSUE STEMS FROM PT BEING VERY LEAN AND ACTIVE (IS A CHEERLEADER) AND THE CANNULA IS KINKING SO SHE IS NOT GETTING THE INSULIN SHE NEEDS. LOCATION OF CANNULA WAS BUTTOCKS. NO ALARM WAS ACTIVATED WITH THE SNAP PUMP SYS. ACCORDING TO THE PT'S MOTHER, HER BLOOD GLUCOSE THE PREVIOUS NIGHT WAS 106 MG/DL, THE MORNING OF THE EVENT BEFORE BREAKFAST IT WAS 295 MG/DL. SHE BOLUSED AND WENT TO SCHOOL WHERE IT WAS THEN AT 500 MG/DL. ASANTE SENT PT EXTRA INFUSION SETS SINCE SHE IS GOING THROUGH THEM SO FAST. ASANTE DISTRIBUTES THE INFUSION SETS WHICH ARE MANUFACTURED BY ANOTHER COMPANY. THE MFR WAS INFORMED OF THIS COMPLAINT ON (B)(6) 2014. ASANTE IS REPORTING THIS EVENT BECAUSE OF OFF-LABEL USE OF THE SNAP INSULIN PUMP SYS IN A PEDIATRIC CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600217 ASANTE SNAP INSULIN PUMP SYS PUMP, INFUSION, INSULIN, 880.5725 LZG ASANTE SOLUTIONS INC. 7115

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R