BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070534 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02013
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT 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.

    Description of Event or Problem · 1

    PT REPORTS HAS NOTICED LEAKING FROM FIVE CARTRIDGES WHEN REMOVED FROM PUMP. BLOOD GLUCOSE LEVEL WOULD RISE TO HIGH 200'S MG/DL WITHOUT KETONES, NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. BLOOD GLUCOSE LEVELS RETURNED TO NORMAL AFTER CARTRIDGE WAS CHANGED. PT'S BLOOD GLUCOSE OF 200 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA DOES NOT MEET ANIMAS CRITERIA AS AN ADVERSE EVENT. THIS REPORT IS BEING MADE BASED ON THE ALLEGATION OF CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1