BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1872145 · Received October 11, 2010

    Report

    Report Number
    2531779-2010-01551
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THERE WAS NO DAMAGE OBSERVED TO THE KEYPAD, THE PUMP INTERMITTENTLY RESPONDED TO BUTTON PRESSES, AND THERE WAS ADHESIVE/CONTAMINATION FOUND UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOTHER CLAIMED THAT THE OK BUTTON STARTED STICKING 2 WEEKS AGO AND THAT IT REQUIRED MULTIPLE PRESSES FOR THE PUMP TO RESPOND. THE REPORTER DENIES STRUCTURAL DAMAGE TO THE PUMP BUT INDICATED THAT THE PAINT HAS WORN OFF THE BUTTONS. THE PUMP REPORTEDLY STILL DELIVERS INSULIN AS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR