BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983295 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00685
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD WAS FOUND TO BE INTACT WITH NO PEELING OR TEARS OBSERVED. THE PUMP WAS OBSERVED TO BE INTERMITTENTLY RESPONSIVE TO UP AND DOWN ARROW BUTTON PRESSES. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. CONTAMINATION WAS FOUND UNDER THE UP AND DOWN ARROW BUTTON 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 DOWN ARROW BUTTON WAS STICKING. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER OR THAT THE KEYPAD WAS DAMAGED. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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