BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2058302 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02228
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THERE IS INADEQUATE INFORMATION TO DETERMINE IF THERE WAS AN ADVERSE EVENT OR A MALFUNCTION OF THE CARTRIDGE. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. THE CARTRIDGES IN QUESTION WERE NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED ELEVATED BLOOD GLUCOSE AND COMPLAINED ABOUT THE SUBSEQUENT ABNORMAL USE OF INSULIN. SHE STATED THAT SHE WOULD LIKE TO BE REIMBURSED FOR COST OF THE ADDITIONAL INSULIN. THE DETAILS OF THE EVENT ARE NOT AVAILABLE AT THIS TIME. THE COMPLAINT IS BEING REPORTED DUE TO THE PAUCITY OF INFORMATION ABOUT THIS ALLEGATION.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention