BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050474 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02274
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY UNRESPONSIVE. VISUAL INSPECTION CONFIRMED THAT THE BUTTON SYMBOLS ARE WORN. THERE IS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN STICKING AND REQUIRE MULTIPLE PRESSES TO OBTAIN A RESPONSE OVER THE PAST MONTH. SHE NOTED THAT THE BUTTONS DO NOT CLICK WHEN PRESSED, AND THE BUTTON SYMBOLS ARE WORN. THE FAMILY MEMBER CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PUMP IS CLEANED WITH ALCOHOL PADS.

    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 12 YR