BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913407 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02595
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SWOLLEN. THE BOLUS BUTTON IS RESPONSIVE TO USER INPUTS DURING TESTING. THE ""UP/DOWN/CONTRAST"" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. WHEN THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION, THE ""UP/DOWN/CONTRAST"" KEY CONTACTS ARE MISALIGNED. THE ""CONTRAST"" KEY CONTACT IS INVERTED. THE ""UP/DOWN/OK"" KEY CONTACTS BECOMES INVERTED WHEN PRESSED AND DO NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS."

    Description of Event or Problem · 1

    THE LAY-USER/PATIENT ALLEGED THAT THE ARROW BUTTONS ON THE KEYPAD IS NON RESPONSIVE. THE KEYPAD REPORTEDLY WAS INTACT. THE BUTTONS FELT SOFT TO PRESS. 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 PUP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1