BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2000578 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00568
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP/DOWN/CONTRAST KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS DURING TESTING, THE OK KEYPAD BUTTON DID NOT RESPOND TO USER INPUTS OR SPRINGBACK DURING TESTING. IT WAS OBSERVED THAT THE OK KEY CONTACT WAS INVERTED, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND 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 KEYPAD BUTTONS REPORTEDLY HAVE TO BE PRESSED SEVERAL TIMES FOR A RESPONSE. 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 CORPORATION ANIMAS 2020 2020

    Patients

    Seq Age Sex Outcome Treatment
    1