BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2213572 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05959
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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 MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED WHILE THERE WAS A LEAKAGE ISSUE WITH THE CARTRIDGE. THE REPORTER COULD NOT PROVIDE ANY NUMERIC VALUES FOR THE ELEVATED BLOOD GLUCOSE AND THE SERIAL NUMBER OF THE EFFECT CARTRIDGE LOT#. IT IS NOT CLEAR WHAT CAUSED THE PATIENT'S ALLEGED ELEVATED BLOOD GLUCOSE AT THE TIME OF CONCERN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY HAD ELEVATED BLOOD GLUCOSE WHILE USING THE ALLEGED ANIMAS 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 16 Life Threatening