BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2180577 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05343
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT REFRIGERATED INSULIN IS BEING USED TO FILL THE CARTRIDGE. THE USER GUIDE INSTRUCTS THE PATIENT TO USE ROOM TEMPERATURE INSULIN WHEN FILLING THE CARTRIDGE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED (350 TO 500MG/DL) WITH KETONES. THE PATIENT'S FATHER REPORTED THAT THERE HAVE BEEN AIR BUBBLES IN THE CARTRIDGE. IT WAS REPORTED THAT REFRIGERATED INSULIN IS BEING USED TO FILL THE CARTRIDGE. THE USER GUIDE INSTRUCTS THE PATIENT TO USE ROOM TEMPERATURE INSULIN WHEN FILLING THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening