BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASANTE SNAP INSULIN PUMP SYSTEM

    MDR report key: 3472036 · Received October 23, 2013

    Report

    Report Number
    3009351200-2013-00002
    Event Type
    Other
    Date Received
    October 23, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 22, 2013
    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

    Description of Event or Problem · 1

    PT CALLED THE ASANTE SUPPORT LINE TO REPORT THAT HE HAD STOPPED USING THE ASANTE SNAP INSULIN PUMP SYSTEM WITH ELI LILLY HUMALOG INSULIN BECAUSE OF AN ALLERGIC REACTION TO THE ELI LILLY HUMALOG INSULIN. THE PT REQUIRED HOSPITALIZATION WHICH INCLUDED BLOOD WORK, X-RAY, AND IV. RESULTS CAME BACK WITH HIGH WHITE BLOOD CELL COUNT. PHYSICIAN SAID IT WAS A VIRUS AND NOT A REACTION TO HUMALOG. PT HAS SUBSEQUENTLY ATTEMPTED TO USE THE ASANTE SNAP INSULIN PUMP SYSTEM WITH ELI LILLY HUMALOG INSULIN TWICE BUT REPORTED HAVING "NEGATIVE HUMALOG REACTIONS" THAT PREVENT HIM FROM CONTINUING. PT IS CURRENTLY IN GOOD HEALTH AND HAS DISCONTINUED USE OF THE ASANTE SNAP INSULIN PUMP SYSTEM. THE ASANTE SYSTEM IS DESIGNED FOR USE WITH ELI LILLY HUMALOG INSULIN CARTRIDGE, BUT THE INSULIN IS NOT DISTRIBUTED BY ASANTE. EACH PT IS RESPONSIBLE FOR OBTAINING HUMALOG INSULIN BY PRESCRIPTION FROM A PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543537 ASANTE SNAP INSULIN PUMP SYSTEM EXTERNAL INSULIN INFUSION PUMP LZG ASANTE SOLUTIONS INC. 7111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization