BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1894600 · Received November 6, 2010

    Report

    Report Number
    2531779-2010-02166
    Event Type
    Malfunction
    Date Received
    November 6, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. THE ANIMAS CDE NOTED THAT THE PT IS CONTRIBUTING TO USE THE PUMP AND WILL NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS LESS RESPONSIVE OK BUTTON PRESSES. THE PT ALSO CLAIMED THAT THE OK BUTTON HAD LESS SPRING THAN USUAL. THE PT DENIED ANY EXPOSURE OF THE DEVICE TO MOISTURE. HE ALSO DENIED ANY EXTERIOR DAMAGE TO THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR