Symphony Glucose Management System

• • Terminated Z-1376-2012 FDA Not yet classified ·initiated 1 Mar 2012

  There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.

• • Terminated Z-2394-2010 FDA Unclassified (pre-2012) ·initiated 18 Mar 2010

  sensor could be damaged

• • Terminated Z-1560-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2009

  Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software.

• • Terminated Z-0955-2009 FDA Unclassified (pre-2012) ·initiated 27 Oct 2008

  incorrect dosing recommendation

• 2 recalls, same reason

  • Terminated Z-0291-2009 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008
  • Terminated Z-0290-2009 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008

  Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.

• • Terminated Z-0283-2009 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008

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

510(k) Number

K080639 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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