BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1934115 · Received December 2, 2010

    Report

    Report Number
    2531779-2010-02680
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP, DOWN AND OK KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE CONTRAST KEYPAD BUTTON WAS UNRESPONSIVE TO USER INPUT, IT WAS OBSERVED THAT THE UP AND OK KEY CONTACTS WERE MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED AND DID NOT ALWAYS SPRING BACK, THE UP, DOWN AND OK KEY CONTACT BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL THE 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 SLOW TO RESPOND WHEN PRESSED. CLAIMED KEYPAD IS 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. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1