BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1874152 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01714
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE PUMP WAS INTERMITTENTLY RESPONDING TO OK BUTTON PRESSES. ADHESIVE/CONTAMINATION AND MOISTURE CORROSION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE KEYPAD WAS INTACT. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO BUTTON PRESSES. THE PT CLAIMED THAT THE PUMP WAS SLOW TO RESPOND TO OK BUTTON PRESSES. THE PT ALSO CLAIMED THAT THE BUTTONS WERE NOT SPRINGING BACK AS USUAL AND HE COULD NOT FEEL CLICKS. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER.

    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 53 YR