BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070847 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02596
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. THE PT REPORTED THAT THE KEYPAD BUTTONS DO NOT RESPOND WITH EVERY BUTTONS PRESS, AND THEN WHEN THE BUTTONS DO RESPOND, THE CURSOR SCROLLS THROUGH THE SCREENS. SHE NOTED THAT THIS HAS OCCURRED ABOUT A DOZEN TIMES IN THE PAST MONTH. THE PT CONFIRMED THAT THE KEYPAD IS NOT PEELING; DENIED EXPOSING THE PUMP TO WATER OR CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP CLIPPED TO HER WAISTBAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR