BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2000579 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00576
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED. THE "UP/DOWN/OK/CONTRAST" KEYPAD BUTTONS REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. THE "UP/DOWN/OK/CONTRAST" KEY CONTACTS WERE OBSERVED TO BE INVERTED. EVIDENCE OF KEYPAD ADHESIVE WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO BUTTON PRESSES. THE PT DENIED ANY TRAUMA TO THE KEYPAD. SHE ALSO DENIED THAT THE DEVICE WAS EXPOSED TO WATER. THE PT CLAIMED THAT THE KEYPAD WAS INTACT AND WAS NOT PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1