BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070493 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-01997
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PT HAS HAD SEVERAL LEAKING CARTRIDGES. SHE NOTED THAT THE HCP INITIALLY THOUGHT, THE PT WAS OVER-FILING THE CARTRIDGES DUE TO THE CARTRIDGE COMPARTMENT HAVING INSULIN IN IT ON SEVERAL OCCASIONS. THE FAMILY MEMBER STATED THAT THE PT'S BLOOD GLUCOSE HAS BEEN IN THE 300 TO 400 MG/DL RANGE WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA AND NO KETONES.

    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 40 YR