BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2050503 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02259
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE PATIENT REPORTED THAT HE HAD 2 INCIDENTS OF LEAKING CARTRIDGES WHILE USING LOT # B201582. HE NOTED THAT HE EXPERIENCED MILD BG ELEVATION WITH BOTH CARTRIDGES, BUT WAS ABLE TO CORRECT WITHOUT MEDICAL INTERVENTION, AS HE CHECKS HIS BG EVERY 2 HOURS. THE PATIENT STATED THAT HE WAS ASYMPTOMATIC WITH BOTH INCIDENTS. HE REPORTED THAT HE NOTICED INSULIN IN THE CARTRIDGE COMPARTMENT WHEN HE WENT TO CHANGE THE CARTRIDGE ON BOTH OCCASIONS. THE PATIENT COULD NOT DETERMINE WHICH END OF THE CARTRIDGES WAS LEAKING.

    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 48 YR