BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2800188 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12602
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS COMPLETED ON (B)(4) 2012 AND TESTING REVEALED THAT ALL BUTTONS RESPONDED INTERMITTENTLY AND THE DOWN BUTTON WAS INVERTED AND SCROLLING. THE KEYPAD WAS TORN AND PEELING AND WAS REMOVED FOR INVESTIGATION. CONTAMINATION WAS NOTED UNDER ALL CONTACTS. THE DISPLAY SCREEN WAS DIM BUT WHEN A TEST DISPLAY WAS USED, THE DISPLAY WORKED NORMALLY. 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 PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED ALL BUTTONS RESPONDING INTERMITTENTLY, CONTAMINATION UNDER ALL CONTACTS, AND A DIM DISPLAY SCREEN. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

    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 17 YR