BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1972612 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00241
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. 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 DURING TESTING, IT WAS OBSERVED THAT THE UP/DOWN/OK/CONTRAST KEYPAD 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 REPORTEDLY NEEDS TO BE PRESSED SEVERAL TIMES FOR A RESPONSE. THE PT CLAIMED THAT THE BUTTON FEELS LOOSER THAN THE OTHER KEYPAD BUTTONS; HOWEVER, REPORTED NO VISIBLE DAMAGE TO THE KEYPAD. 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 CORPORATION ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1