BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913036 · Received November 3, 2010

    Report

    Report Number
    2531779-2010-02080
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND THE EVAL REVEALED THAT THE KEYPAD WAS INTACT WITH NO LIFTING OR PEELING. ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND THE "UP/DOWN" KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THE "OK" KEY CONTACT WAS OBSERVED TO BE INVERTED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE BUTTONS HAVE TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD.

    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