BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2073100 · Received April 13, 2011

    Report

    Report Number
    2531779-2011-02754
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 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
    FL, US
    Reporter Occupation
    OTHER

    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 # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT. A FAMILY MEMBER STATED THAT THE PT'S BLOOD GLUCOSE WAS BETWEEN 390 MG/DL AND 400 MG/DL DUE TO THE LEAKAGE; HE DENIED THE PRESENCE OF KETONES, SYMPTOMS OF HYPERGLYCEMIA, OR MEDICAL INTERVENTION. THE FAMILY MEMBER REPLACED THE CARTRIDGE AND INFUSION SET, DELIVERED A CORRECTION BOLUS OF INSULIN VIA INJECTION, AND SAID THAT THE PT'S BLOOD GLUCOSE RESOLVED TO HIS USUAL RANGE. HE SAID THAT HE WAS UNAWARE OF ANY OTHER CARTRIDGES THAT LEAKED.

    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 B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR