BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1893681 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-02001
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS OBSERVED TO BE SWOLLEN. THE KEYS WERE ALL FOUND TO BE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE 'UP' BUTTON IS TAKING SEVERAL PRESSES TO RESPOND. THE PT REPORTS THE KEYPAD IS INTACT AND THE PUMP IS NOT EXPOSED TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR