BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042164 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02038
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE REPORTER, THE PT'S MOTHER, REPORTED THAT SINCE (B)(6) 2010 THE PT OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 300 MG/DL TO 500 MG/DL. ON (B)(6) 2011 THE PT OBTAINED THE BLOOD GLUCOSE READING OF 550 MG/DL. THE PT EXPERIENCED THE SYMPTOMS OF LETHARGY, DIZZINESS AND HEADACHE. THE PT REC'D A CORRECTION VIA THE PUMP AND TWO HOURS LATER HIS BLOOD GLUCOSE LEVEL WAS 300 MG/DL. ON THAT DATE, THE PT'S MOTHER NOTED THE INSULIN CARTRIDGE WAS LEAKING.

    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 B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R