BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4192286 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29940
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    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 400 MG/DL WITH POLYDIPSIA, POLYURIA, AND NAUSEA. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO THE HYPERGLYCEMIC EVENT THE PATIENT EXPERIENCED DUE TO AN ALLEGED OCCLUSION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673655 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR