BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2060731 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02399
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS RETURNED TO ANIAMS FOR EVAL. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. A CRACK IN THE BODY OF THE CARTRIDGE WAS OBSERVED. A CARTRIDGE LEAK TEST COULD NOT BE PERFORMED BECAUSE OF THE CRACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING. THE PT REPORTED THAT HE FILLED A NEW CARTRIDGE, AND NO INSULIN WAS SEEN DURING THE PRIME STEP. HE STATED THAT HE CHECKED THE CARTRIDGE COMPARTMENT, AND IT WAS FILLED WITH INSULIN. THE PT THEN NOTED THAT THE CARTRIDGE WAR BROKEN AT THE PLUNGER END OF THE CARTRIDGE. HE REPORTED THAT THIS CARTRIDGE IS FROM LOT# B201445, AND THAT HE HAS USED 6 OTHER CARTRIDGES FROM THIS LOT WITHOUT ANY PROBLEMS.

    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 B201445

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR