BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070765 · Received April 14, 2011

    Report

    Report Number
    2531779-2011-02556
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. ALL KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS DURING TESTING. DURING INVESTIGATION, ALL KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. THE BOLUS BUTTON WAS REMOVED AND CONTAMINATION WAS FOUND ON THE CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUDIO BOLUS PROGRAMMING SCREEN IS CONTINUOUSLY APPEARING. THE PT REPORTED THAT SHE CANNOT NAVIGATE THROUGH THE PUMP BECAUSE, EVERY BUTTON PRESS TAKES HER TO THE AUDIO BOLUS PROGRAMMING SCREEN. SHE REPORTED THERE IS NO PHYSICAL DAMAGE TO THE KEYPAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1