BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1893674 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-02006
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND THE EVALUATION REVEALED THAT THE KEYPAD WAS SWOLLEN. ADDITIONALLY, ALL KEYS WERE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. THE KEYPAD WAS REMOVED AND THE "UP/OK" KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE 'UP' BUTTON HAS BEEN STICKING FOLLOWING BUTTON PRESSES. WHEN ATTEMPTING TO ENTER A BOLUS, THE STICKING 'UP' BUTTON CAUSED THE BOLUS AMOUNT TO INCREASE TO THE MAXIMUM BOLUS AMOUNT. THE 'DOWN' BUTTON ONLY RESPONDS INTERMITTENTLY AND REQUIRES MULTIPLE PRESSES TO ELICIT A RESPONSE. THE 'OK' BUTTON IS NOT RESPONDING WHEN THE 'UP' BUTTON IS STUCK. ALL BUTTONS ARE FLAT WHEN PRESSED AND DO NOT SPRING BACK. THE REPORTER DENIES VISIBLE DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE.

    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