BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1874184 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01669
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE BOLUS BUTTON WAS TORN AT THE CENTER AND REQUIRED HARD PRESSES TO ACHIEVE A PUMP RESPONSE. CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PT ALLEGED THAT THE PUMP REQUIRED MULTIPLE PRESSES FROM THE ARROW AND AUDIO BOLUS BUTTONS TO RESPOND. THE PT DID NOT NOTICE ANY KEYPAD PEELING.

    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 53 YR