BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942214 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03019
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 APPEARS TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE DOWN/OK/UP KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE TO USER INPUT DURING TESTING, ALL KEYPAD BUTTONS SPRUNG BACK NORMALLY WHEN PRESSED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION 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 KEYPAD BUTTONS REPORTEDLY UNRESPONSIVE WHEN PRESSED. 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