BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1881520 · Received October 19, 2010

    Report

    Report Number
    2531779-2010-01746
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 20, 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 HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE PT'S MOTHER, THE UP AND DOWN ARROW BUTTONS ARE STICKING AND THEY REQUIRE MULTIPLE PRESSES FOR THE PUMP TO RESPOND. THE UP AND DOWN ARROW SYMBOLS ARE REPORTEDLY ALMOST WORN OFF. THE REPORTER CLAIMED THE PUMP HAS NOT BEEN EXPOSED 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