BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2070494 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-01996
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT ADDRESSES A CARTRIDGE LEAKAGE AT THE LUER LOCK CONNECTION BETWEEN THE CARTRIDGE AND THE TUBING. ALTHOUGH, THE CARTRIDGE IS FROM A LOT NUMBER THAT WAS PART OF A RECALL, THERE IS NO INDICATION THAT THIS PARTICULAR LEAK COMPLAINT IS RELATED TO THE RECALL. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PT SAID THAT SHE NO LONGER HAD THE CARTRIDGE OR TUBING AVAILABLE FOR INVESTIGATION AS THIS ALLEGED ISSUE OCCURRED ABOUT (B)(6) AGO. INVESTIGATION OF A RETAINED SAMPLE WILL BE CONDUCTED, AND 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 PT REPORTED INSULIN LEAKAGE FROM THE CARTRIDGE WHERE THE FILLING NEEDLE ATTACHED TO THE TOP OF THE CARTRIDGE. SHE STATED THAT SHE NOTICED THE ISSUE WHEN SHE WAS FILLING THE CARTRIDGE FROM THE VIAL OF INSULIN. THE PT REPORTED THAT A BUBBLE APPEARED TO LEAK OUT AROUND THE CONNECTION BETWEEN THE NEEDLE AND THE TOP OF THE CARTRIDGE.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR