BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1945217 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03107
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT, NO LIFTING OR PEELING. THE "UP/DOWN/OK" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. THE "CONTRAST" KEYPAD BUTTON IS RESPONSIVE TO USER INPUTS DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. DURING A VISUAL INSPECTION, THE "UP/OK" KEY CONTACTS ARE MISALIGNED, THE "UP/DOWN/OK" KEY CONTACTS BECOMES INVERTED WHEN PRESSED AND DO NOT ALWAYS SPRING BACK, AND THE "CONTRAST" KEY CONTACT CLICK AND SPRING BACK NORMALLY WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD MALFUNCTION. THERE WAS NO REPORT OF PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1