BEUDAMED
    FDA Recall Terminated

    One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.

    Recall: Z-0283-2009 · Initiated August 4, 2008

    Recall

    Recall Number
    Z-0283-2009
    Event Number
    49475
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 4, 2008
    Posted
    November 7, 2008
    Terminated
    November 12, 2008
    Address
    200 Lawrence Dr, West Chester, PA, 19380

    Description

    One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.

    Reason

    display old, inaccurate values for bolus amount delivered and amount of planned bolus totals

    Action

    On 8/6/08, the recalling firm telephoned all users to inform them of problem and the need to return the system.

    Distribution

    Nationwide Distribution

    Quantity

    251 units