BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1935496 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02870
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 INTACT NO LIFTING OR PEELING. THE "UP/DOWN/OK" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING TO USER INPUTS DURING TESTING. THE "CONTRAST" KEYPAD BUTTON REQUIRES EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. FURTHER INVESTIGATION SHOWED THE "CONTRAST" KEY CONTACT IS INVERTED, AND THE "UP/DOWN/OK" KEY CONTACTS BECOME INVERTED WHEN PRESSED AND DO NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE LAY-USER/PT ALLEGED THAT THE BUTTONS ON THE KEYPAD DO NOT RESPOND. THERE WAS PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, 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