BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4192352 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29944
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT NOT USING CARTRIDGE PER IFU).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING AN OCCLUSION ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF OVER 500MG/DL WITH RAPID, DEEP BREATHING, SHORTNESS OF BREATH, CHEST PAIN AND CHEST TIGHTNESS. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND IT WAS DETERMINED THAT THE PATIENT IS NOT USING THE CARTRIDGE PER IFU. THIS REPORT IS BEING MADE DUE TO THE HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED THAT RESULTED FROM AN NOT USING CARTRIDGE PER IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674249 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening