BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1972586 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00239
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP/DOWN/OK/CONTRAST KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, IT WAS OBSERVED THAT THE UP KEYPAD CONTACT WAS MISALIGNED, 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 FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE DOWN ARROW KEYPAD BUTTON IS INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. THE PT CLAIMED THAT THE BUTTON FEELS NORMAL TO PRESS AND THE KEYPAD IS INTACT. 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