BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2211181 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05869
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 16, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NOT CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT INSULIN LEAKED INTO THE CARTRIDGE COMPARTMENT AND THE DISPLAY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1