BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1913668 · Received November 22, 2010

    Report

    Report Number
    2531779-2010-02477
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE SWOLLEN, THE UP/DOWN/OK BUTTONS WERE INTERMITTENTLY RESPONDING AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, THE CONTRAST BUTTON REQUIRED EXCESSIVE FORCE TO ACTIVATE, THE UP KEY CONTACTS WAS MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED AND DID NOT ALWAYS SPRING BACK, THE UP/DOWN/OK KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES WERE INTERMITTENTLY ACTIVATING THE DESIRED PUMP FUNCTIONS AND WERE STICKING. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE AND THERE IS NO STRUCTURAL DAMAGE TO THE KEYPAD. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1