BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3180227 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08625
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING AIR BUBBLES IN THE CARTRIDGE RESULTING FROM ISSUES WITH THE LUBRICATION OF THE CARTRIDGE. THE DISTRIBUTOR REPORTED THAT THIS WAS AN ISSUE WITH SEVERAL CARTRIDGES FROM THE SAME LOT NUMBER. THE DISTRIBUTOR REPORTED THAT THIS ISSUE CAUSED THE PATIENT TO EXPERIENCE HYPERGLYCEMIA OF AN UNREPORTED MEASUREMENT AND NO REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THERE WAS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE IF THERE WAS A REPORTABLE ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER REPORTED AIR BUBBLES FORMING IN THE INSULIN CARTRIDGE DUE TO A LUBRICATION ISSUE WITH THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279486 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1