BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1904160 · Received November 15, 2010

    Report

    Report Number
    2531779-2010-02283
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING. THE "DOWN" KEYPAD BUTTON WAS INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE. THE "UP" AND "OK" KEYPAD BUTTONS WERE UNRESPONSIVE. THE KEYPAD WAS REMOVED AND ALL OF THE KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK. THERE WAS ALSO EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE BUTTONS HAVE TO BE PRESSED MULTIPLE TIMES TO ELICIT A RESPONSE FROM THE KEYPAD. THE BUTTONS FEEL NORMAL WHEN PRESSED AND THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR