BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2864712 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14369
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    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. 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) 2012 REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS; THE PATIENT WAS REPORTED TREATED WITH INTRAVENOUS FLUIDS AND INSULIN AND THE ISSUE WAS RESOLVED. THE REPORTER STATED THAT THE PATIENT HAD ELEVATED BLOOD GLUCOSE AND WHILE ATTEMPTING TO CONNECT A NEW INFUSION SET, THE CARTRIDGE WAS REMOVED AND INSULIN WAS FELT COMING OUT OF THE CARTRIDGE COMPARTMENT. CUSTOMER SUPPORT HAD THE REPORTER REMOVE THE CARTRIDGE AND ATTEMPT A MANUAL PRIME; THE CARTRIDGE WAS NOTED TO BE LEAKING FROM THE SIDE OF THE LUER CONNECTION JUST BELOW THE TOP OF THE CARTRIDGE. THE REPORTER CONFIRMED THAT THERE WAS NO NOTED DAMAGE TO THE CARTRIDGE OR TUBING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AFTER A REPORTED CARTRIDGE LEAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L