BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1872141 · Received October 11, 2010

    Report

    Report Number
    2531779-2010-01557
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE PUMP IS INTERMITTENTLY RESPONDING WHEN THE BUTTONS ARE PRESSED AND THE BUTTONS REQUIRE MULTIPLE PRESSES FOR A RESPONSE. THE PT INDICATED THAT THE PUMP HAS GOTTEN WET BUT IS STILL ABLE TO USE THE PUMP. THE PT REFUSED TO RETURN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR