BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042167 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02030
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THAT ON (B)(6) 2011 THE PT OBTAINED THE ELEVATED BLOOD GLUCOSE READING OF 360 MG/DL AND SHE TESTED POSITIVE FOR KETONES. AT THAT TIME, THE PT EXPERIENCED THE SYMPTOMS OF NAUSEA AND BLURRED VISION. AT 11:11 PM THE PT CHANGED THE CARTRIDGE AND OBSERVED INSULIN LEAKING FROM THE TUBING CONNECTION TO THE CARTRIDGE, AND THE CARTRIDGE COMPARTMENT SMELLED OF INSULIN. AT 12:00AM THE PT CHANGED THE CARTRIDGE AGAIN, AND HER BLOOD GLUCOSE LEVEL RESPONDED TO THE BOLUSES DELIVERED. TROUBLESHOOTING REVEALED THERE WAS NO PROBLEM WITH THE INFUSION SITE, THERE WAS NO BLOOD IN THE CANNULA, THE PUMP'S PROGRAMMING WAS CORRECT, AND THE TOTAL DAILY DOSES OF INSULIN DELIVERED MATCHED THE BASAL/BOLUSES PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Life Threatening| R| R| L NA.| NA.
    1 31 YR Female Life Threatening| R| R| L NA.| NA.