BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2922857 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00871
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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. LOT NUMBER: B201877.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE CARTRIDGE HAS AIR BUBBLES WHEN HE FILLS UP THE CARTRIDGE. THE PATIENT CONFIRMED THAT THEY HAVE BEEN USING ROOM TEMPERATURE INSULIN. THE PATIENT STATED HE IS NOT INJECTING AIR INTO THE INSULIN, THEY INJECT IT INTO THE AIR PORTION OF THE VIAL. THEY STATED THAT THEY PRIMED OUT THE AIR WHEN THE CARTRIDGE IS FILLED. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE AIR BUBBLES IN CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27547 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR