BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3014276 · Received March 21, 2013

    Report

    Report Number
    2531779-2013-02884
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE REPORTER INDICATED THAT THE PATIENT'S BLOOD GLUCOSE BEGAN INCREASING ON (B)(6) 2013; THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 231 MG/DL WHICH INCREASED TO 330 MG/DL AFTER ARRIVING HOME, THE PATIENT'S BLOOD GLUCOSE REPORTED INCREASED TO 500 MG/DL WITH KETONES AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE REPORTER WAS UNABLE TO RECALL THE TREATMENT THE PATIENT RECEIVED; THE REPORTER INDICATED THAT AS THE PATIENT WAS BEING DISCHARGED, THE PATIENT BEGAN VOMITING AND BLOOD GLUCOSE LEVELS INCREASED AGAIN. THE PATIENT WAS REPORTEDLY TREATED WITH INTRAVENOUS INSULIN. THE PUMP WAS REVIEWED WITH THE REPORTER. THE REPORTER INDICATED THAT THE PUMP SETTINGS WERE CORRECT. THE REPORTER CONFIRMED THAT THE TOTAL DAILY DOSE HISTORY WAS AS EXPECTED WITH NO ISSUES FOUND, THE BOLUS HISTORY WAS AS EXPECTED AND CONFIRMED ALL BOLUSES WERE COMPLETED. CUSTOMER SUPPORT ADVISED THE REPORTER THAT THERE WAS NO INDICATION THAT THE PUMP WAS NOT DELIVERING AS PROGRAMMED. THE REPORTER REMOVED THE CARTRIDGE FROM THE PUMP AND INDICATED THAT AIR BUBBLES WERE NOTED IN THE CARTRIDGE; THE REPORTER INDICATED THAT THE CARTRIDGE WAS FIRST PLACED IN THE PUMP ON (B)(6) 2013. TROUBLESHOOTING OF THE CARTRIDGE FILLING TECHNIQUE INDICATED THAT REFRIGERATED INSULIN WAS USED IN THE CARTRIDGE. THE REPORTER WAS ADVISED ON ALLOWING THE INSULIN TO COME TO ROOM TEMPERATURE PRIOR TO FILLING THE CARTRIDGE AND ALLOW THE CARTRIDGE TO DEBUBBLE PRIOR TO INSERTING INTO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ASSOCIATED WITH IMPROPER CARTRIDGE FILLING TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118803 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| L