BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1934085 · Received December 2, 2010

    Report

    Report Number
    2531779-2010-02683
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SWOLLEN. THE PUMP WAS RETURNED WITH THE KEYPAD LIFTING UP BELOW THE "OK" BUTTON. THE "UP/DOWN/OK" KEYPAD BUTTON IS INTERMITTENTLY RESPONDING DURING TESTING. THE "CONTRAST" KEYPAD BUTTON REQUIRE EXCESSIVE FORCE TO ACTIVATE. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. DURING A VISION INSPECTION, THE "CONTRAST" KEY CONTACT IS INVERTED AND DO NOT ALWAYS SPRING BACK, AND THE "UP/DOWN/OK" KEY CONTACTS BECOME 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 DISTRIBUTOR/REPORTER ALLEGED THAT THE UP AND DOWN BUTTONS ON THE KEYPAD DOES NOT RESPOND. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1