BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2043299 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01574
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DOWN ARROW AND OK BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE UP ARROW AND CONTRAST BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE A RESPONSE. DURING INVESTIGATION, ALL BUTTONS WERE OBSERVED TO BE MISALIGNED. IT WAS ALSO OBSERVED THAT ALL BUTTONS DO NOT ALWAYS SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP ARROW BUTTON IS NOT RESPONDING. IT WAS ALSO REPORTED THERE ARE NO SIGNS OF STRUCTURAL DAMAGE AND THERE IS NO EXPOSURE TO WATER.

    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