BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1963901 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00094
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    December 11, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED, THE UP/DOWN/OK/CONTRAST KEYPAD BUTTONS INTERMITTENTLY RESPONDED TO USER INPUTS AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING, IT WAS OBSERVED THAT THE UP/CONTRAST KEY CONTACTS WERE MISALIGNED, THE CONTRAST KEY CONTACT WAS INVERTED, THE UP/DOWN/OK KEY CONTACTS BECAME INVERTED WHEN PRESSED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE KEYPAD BUTTONS REPORTEDLY UNRESPONSIVE WHEN PRESSED ON THE VERIFICATION SCREEN. THE PT'S MOTHER CLAIMED THAT SHE WAS ABLE TO NAVIGATE THE PUMP SCREENS SUCCESSFULLY AFTER REBOOTING THE PUMP; HOWEVER, THE KEYPAD BUTTONS WERE DIFFICULT TO PRESS. THE REPORTER CLAIMED THAT THE KEYPAD WAS INTACT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1