BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042176 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02054
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(4), 2011, THE PT REPORTED THAT HIGH BLOOD GLUCOSE (BG) READINGS SINCE CHANGING INFUSION SET THE DAY PRIOR. THE PT CLAIMED HIS BG HAS BEEN GREATER THAN 250 MG/DL. THE PT STATED HE DOES NOT CHECK HIS KETONES BUT CONFIRMED HAVING THE SYMPTOM OF INCREASED THIRST. THE PT REPORTED ADMINISTERING AN INJECTION IN RESPONSE TO THE HIGH BGS. AT THE TIME OF TROUBLESHOOTING, THE PT CONFIRMED THAT THE CANNULA IS STRAIGHT AND REPORTED SEEING A FEW BUBBLES IN THE CARTRIDGE. THE PT WAS ADVISED TO CHANGE OUT INFUSION SET AND INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020 / OTP

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR