BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913413 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02574
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 APPEARS TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP KEYPAD BUTTON IS INTERMITTENTLY RESPONDING AND REQUIRES EXCESSIVE FORCE TO ACTIVATE, IT WAS OBSERVED THAT THE CONTRAST KEYPAD BUTTON WAS UNRESPONSIVE TO USER INPUTS, BOTH THE DOWN AND OK KEYPAD BUTTONS ARE RESPONSIVE, IT WAS OBSERVED THAT THE UP AND CONTRAST KEY CONTACTS WERE INVERTED, THE DOWN AND 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 DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE UP ARROW KEYPAD BUTTON INTERMITTENTLY RESPONDING WHEN PRESSED. IT WAS REPORTED THAT THE BUTTONS SPRING AND CLICK NORMALLY AND THAT THE KEYPAD IS STILL 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. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1