BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3083294 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05546
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS REPORTEDLY DISCARDED AND IS NOT EXPECTED TO RETURN TO ANIMAS. THE PATIENT INDICATED THAT THE SUPPLIES WERE USED FOR 5 DAYS AND THE SUPPLIES WERE OCCASIONALLY REUSED. THE CARTRIDGES ARE LABELLED AS A SINGLE USE DEVICE. ADDITIONALLY THE USER GUIDE INSTRUCTS THE PATIENT TO REVIEW THE LABELING FOR THE INSULIN AND TO CONSULT WITH A HEALTH CARE PROFESSIONAL REGARDING THE FREQUENCY OF CARTRIDGE CHANGES.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE OF 276 MG/DL WITH POSITIVE KETONES, NAUSEA, ABDOMINAL PAIN, INCREASED THIRST, AND FREQUENT URINATION ASSOCIATED WITH OCCLUSION ALARMS. TROUBLESHOOTING OF THE EVENT INDICATED THAT THE PATIENT WAS USING SUPPLIES FOR 5 DAYS, OCCASIONALLY REUSING SUPPLIES, AND WAS NOT CYCLING THE CARTRIDGE PRIOR TO FILLING. THE PATIENT CONFIRMED THAT THE SUPPLIES WERE NOT EXPIRED AT THE TIME OF THE ISSUE. THE PATIENT WAS ADVISED ON THE OCCLUSION ALARM FEATURE AND WAS ADVISED ON THE POSSIBLE REASONS FOR THE OCCLUSION ALARMS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR OF THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184501 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening