BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3200873 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09447
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING AN INSULIN LEAK AT THE CARTRIDGE AND INFUSION SET LUER CONNECTION. THE PATIENT INDICATED THAT THE ISSUE WAS NOTED WHEN PRIMING THE TUBING AFTER A BATTERY CHANGE. THE PATIENT INDICATED THAT THERE WAS AN INSULIN SMELL ALL DAY LONG BUT DID NOT REALIZE THE INSULIN WAS COMING FROM THE CARTRIDGE CONNECTION. THE PATIENT REPORTED HAVING ELEVATED BLOOD GLUCOSE LEVELS UP TO 275 MG/DL. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE LUER CONNECTION LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303234 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR