BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3983753 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22554
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 400MG/DL WITH MODERATE KETONES ASSOCIATED WITH AIR BUBBLES IN THE CARTRIDGE. REPORTEDLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT FOR THE ALLEGED BG EXCURSION. THE REPORTER NOTED THAT THE AIR BUBBLE ISSUE HAD OCCURRED WITH FIVE DIFFERENT CARTRIDGES SINCE (B)(6) 2014. TROUBLESHOOTING INDICATED THAT THE CARTRIDGES WERE BEING USED APPROPRIATELY PER THE INSTRUCTIONS FOR USE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AIR BUBBLES IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460617 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION D201927

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening