BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1931763 · Received December 8, 2010

    Report

    Report Number
    2531779-2010-02780
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE UP/DOWN BUTTON WERE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING, THE OK/CONTRAST BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE CONTRAST KEY CONTACT WAS INVERTED, THE UP/DOWN/OK KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES WAS NOT ACTIVATING THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY IS INTACT AND THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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