BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2033829 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01851
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    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. ALL KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE DURING TESTING. DURING INVESTIGATION, THE UP ARROW AND DOWN ARROW KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. ALL KEYPAD BUTTONS INTERMITTENTLY SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, OK, AND CONTRAST BUTTONS REQUIRED SEVERAL PRESSES TO ACTIVATE A RESPONSE. IT WAS REPORTED THAT THE PUMP IS NOT EXPOSED TO WATER, AND THERE ARE NO VISIBLE TEARS OR PEELING ON KEYPAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1