BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3111866 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06363
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING ELEVATED BLOOD GLUCOSE (BG) DUE TO OCCLUSION ALARMS. THE PATIENT REPORTED BG UP TO 400MG/DL; AT THE TIME OF THE INITIAL CALL TO ANIMAS THE PATIENT'S BG WAS REPORTEDLY 387MG/DL AND THE PATIENT WAS NOT THINKING CLEARLY DURING TROUBLESHOOTING. THE PATIENT HAD REPORTEDLY GIVEN CORRECTIVE INSULIN FOR THE ELEVATED BG. THE PATIENT REPORTEDLY CHANGED HER SITE THE PREVIOUS DAY AS IT WAS DUE TO BE CHANGED, AND RECEIVED A RANDOM OCCLUSION ALARM AFTER THE SITE CHANGED. THE PATIENT PERFORMED A REWIND, LOAD, AND PRIME AND RECONNECTED TO THE SAME SITE, AND RECEIVED ANOTHER OCCLUSION ALARM AT 4AM. THE PATIENT THEN REPORTEDLY CHANGED OUT ALL HER SUPPLIES. THE PATIENT REPORTEDLY DOES NOT CYCLE CARTRIDGES AND DOES NOT ALWAYS CHANGE SITES FOR OCCLUSION ALARMS. THE CUSTOMER TECHNICAL SUPPORT (CTS) REPRESENTATIVE ATTEMPTED TO REVIEW INSERTION TECHNIQUE WITH THE PATIENT, BUT THE PATIENT COULD NOT FOLLOW THE CONVERSATION. THE PATIENT NOTED SHE HAD LOST CLOSE TO 10 POUNDS AND HAS BEEN RUNNING. THE PATIENT REPORTEDLY WAS USING ONLY HER ABDOMEN FOR INSERTION SITES. CTS ADVISED THE PATIENT TO CONTACT HER HEALTHCARE PROVIDER TO DISCUSS SITES AND POSSIBLY USE OF OTHER INFUSION SETS, AND ADVISED THE PATIENT ON PROPER CARTRIDGE CYCLING AND CLEARING OF OCCLUSION ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213413 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening