BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1882924 · Received October 22, 2010

    Report

    Report Number
    2531779-2010-01862
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO OK BUTTON, AND UP AND DOWN ARROW BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THE KEYPAD WAS TORN NEAR THE UP ARROW BUTTON.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS HAVING DIFFICULTY RESPONDING TO BUTTON PRESSES.

    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