BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3872078 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16956
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE PATIENT HAD EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) THAT SAME DAY OF 400MG/DL WITH KETONES, NAUSEA, AND ABDOMINAL PAIN/VOMITING. THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN INJECTIONS AT AN URGENT CARE CLINIC. TROUBLESHOOTING INDICATED AIR BUBBLES IN THE CARTRIDGE. 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
    349009 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R