BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2123537 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04145
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE (BG) WAS 485MG/DL WITH NAUSEA AND NOT FEELING WELL. HE TREATED HIMSELF WITH AN INSULIN INJECTION. IN A FOLLOW-UP PHONE CALL HIS BG REACHED 501MG/DL. HE NOTICED WHEN HE WENT TO CHANGE HIS CARTRIDGE THERE WAS INSULIN IN THE CARTRIDGE COMPARTMENT. THE PATIENT STATED THAT THIS IS THE THIRD CARTRIDGE FROM THE SAME BOX THAT HE NOTICED WAS LEAKING. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT ASSOCIATED WITH A LEAKY CARTRIDGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention