BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2150063 · Received July 5, 2011

    Report

    Report Number
    2531779-2011-04684
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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'S MOTHER CALLED ANIMAS REPORTING THAT THERE WERE AIR BUBBLES AT THE TOP OF THE CARTRIDGE. SHE SAID THAT WHEN WAKING UP THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 116 MG/DL WITH TRACE KETONES. AT LUNCH HER BLOOD GLUCOSE WAS 120 MG/DL AND THE PATIENT HAD MILD/MODERATE KETONES. IN THE AFTERNOON THE PATIENT CHECKED THE PATIENT'S KETONES AND NOTICED A VERY HIGH CONCENTRATION SO THE PATIENT WENT TO THE HOSPITAL. SHE TOLD THE PATIENT TO DRINK A LOT OF FLUIDS BUT THE AMOUNT OF KETONES WAS NOT DECREASING SO THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE HOSPITAL WAS 160 MG/DL AND THE PATIENT WAS GIVEN IV FLUIDS. THE PATIENT'S MOTHER SAID THE PATIENT'S BREATH SMELLED FUNNY AND THE PATIENT HAS BEEN IRRITABLE. SHE SAID THE PATIENT FELT NAUSEATED THE DAY PRIOR TO CALLING ANIMAS. THE HEALTH CARE PROFESSIONAL AT THE HOSPITAL HOWEVER FEELS THE PATIENT IS NOT ILL. ALTHOUGH THE PATIENT'S BLOOD GLUCOSE LEVELS DID NOT ELEVATE THE PATIENT'S MOTHER FELT THE AIR BUBBLES IN THE CARTRIDGE CONTRIBUTED TO THE KETONES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L| R