BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2153773 · Received July 8, 2011

    Report

    Report Number
    2531779-2011-04774
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE TESTING CONFIRMED THAT THERE WAS NO RESPONSE TO BUTTON PRESSES ON KEYPAD FOR ALL THE BUTTONS. UNABLE TO ADVANCE BEYOND VERIFY SCREEN BECAUSE OF UNRESPONSIVE BUTTONS. PRODUCT ANALYSIS PERFORMED AN IN-HOUSE LEAK TEST AND FOUND A KEYPAD LEAK. REMOVED KEYPAD COVER TO CHECK CONDITION OF BUTTON CONTACTS. CORROSION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM OR DUPLICATE MOISTURE IN CARTRIDGE COMPARTMENT. EXAMINED COMPARTMENT UNDER MAGNIFICATION. NO EVIDENCE OF MOISTURE IN CARTRIDGE COMPARTMENT. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE UP/DOWN BUTTONS WERE LOCKED AND THEN UP AND DOWN ARROWS WERE CONTINUALLY SCROLLING WHEN PRESSED. THE PATIENT WAS WEARING THE PUMP IN THE POOL AND THE PUMP HAD BEEN EXPOSED TO MOISTURE. THERE WAS NO ADVERSE EVENT ASSOCIATE WITH THIS COMPLAINT. THE PUMP WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR