BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1901640 · Received November 10, 2010

    Report

    Report Number
    2531779-2010-02236
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 13, 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 HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO KEYPAD BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE/ CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. IN ADDITION, THE BUTTON CONTACTS WERE OBSERVED TO BE INVERTED AND WERE NOT ALWAYS SPRINGING BACK. THE KEYPAD ALSO APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. THERE WERE NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) ALLEGING THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO OK BUTTON PRESSES. SHE DENIED THAT THE PUMP WAS EXPOSED TO MOISTURE OR TRAUMA. SHE ALSO DENIED THAT THE KEYPAD WAS PEELING.

    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