BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2980195 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02199
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE INSTRUCTIONS FOR USE CLEARLY INDICATE THAT THE CARTRIDGE IS INDICATED FOR USE AS A RESERVOIR FOR INSULIN TO BE USED WITH THE ANIMAS AND ONE TOUCH INSULIN PUMPS; THE CARTRIDGE IS NOT INTENDED FOR OTHER INFUSION USES. THE CARTRIDGE HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS AT THIS TIME. 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 WOKE UP WITH PARAMEDICS AROUND AND THE PATIENT WAS RUSHED TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED AT THAT TIME. ANIMAS WAS ABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER (HCP) ON (B)(4) 2012. THE HCP NOTES INDICATED THAT THE PATIENT WAS FOUND UNCONSCIOUS ON THE FLOOR AND EMERGENCY MEDICAL SERVICES WERE CALLED. THE PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY MEASURED AT 27 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS DEXTROSE AND THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT WAS REPORTEDLY NOT WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT RELATED TO RUNNING OUT OF SUPPLIES. THE PATIENT WAS REPORTEDLY RUNNING ELEVATED BLOOD GLUCOSE WHILE OFF OF THE PUMP; THE HCP NOTE INDICATED THAT THE PATIENT EVENTUALLY USED THE CARTRIDGE AS A SYRINGE A DELIVERED TWO INJECTIONS, 11:45 AM IN THE AMOUNT OF 20 UNITS AND 12:30 PM IN THE AMOUNT OF 40 UNITS. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT ATTEMPTED TO USE THE PUMP INSULIN CARTRIDGE TO DELIVER AN INJECTION RESULTING IN HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85439 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L