Animas Model IR1250 Insulin Infusion Pump

• • Terminated Z-0993-2013 FDA Class I ·initiated 3 Jan 2013

  Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

• • Terminated Z-0836-2013 FDA Class III ·initiated 17 Dec 2012

  Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.

• 2 recalls, same reason

  • Terminated Z-0292-2009 FDA Unclassified (pre-2012) ·initiated 4 Aug 2008
  • Terminated Z-0294-2009 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-0309-06 FDA Unclassified (pre-2012) ·initiated 31 Oct 2005

  Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

• • Terminated Z-0929-05 FDA Unclassified (pre-2012) ·initiated 11 Apr 2005

  pump failed to respond to keypad button pressess after using the food database feature

510(k) Number

K042873 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ez Set Infusion Set

  Class II

  FDA 510(k) K012754 Active Cleared 27 Aug 2001

• Ezmanager Max Diabetes Management Software

  Class II

  FDA 510(k) K063674 Active Cleared 30 Mar 2007

• R1000 Series Insulin Pump

  Class II

  FDA 510(k) K993184 Active Cleared 10 Feb 2000

• Model IR 1200 Insulin Pump

  Class II

  FDA 510(k) K032257 Active Cleared 16 Oct 2003

• Ez Manager Max Diabetes Management Software

  Class II

  FDA 510(k) K080587 Active Cleared 15 May 2008

• Symphony Glucose Management System

  Class II

  FDA 510(k) K080639 Active Cleared 24 Jun 2008

See all devices from Animas Corp. →

• How is the Animas Model IR1250 Insulin Infusion Pump intended to be used in clinical practice?

  The Animas Model IR1250 is designed for subcutaneous insulin delivery in insulin-dependent patients with diabetes mellitus. It provides programmable basal and bolus insulin rates to help manage blood glucose levels. The pump operates with a DC motor, delivering insulin in precise increments—basal doses in 0.05 unit/hour steps every three minutes and bolus doses in 0.1 unit increments. It is paired with disposable infusion sets, ensuring single-use per patient.

• Is the pump itself reusable, or does the entire system need to be discarded after use?

  The Animas Model IR1250 pump itself is reusable, but it requires disposable insulin infusion sets for each patient. This design ensures sterility and safety, as the infusion sets are intended for single-use only. The reusable pump body is cleaned and prepared for the next patient’s use, while the disposable components (like the infusion set) are discarded after one use.

• What storage and handling guidelines should be followed for the Animas Model IR1250?

  The Animas Model IR1250 follows standard medical device storage and handling protocols to maintain its functionality and safety. Since it is a reusable electronic device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The disposable infusion sets should be handled according to manufacturer instructions, typically stored in their original packaging until use. Compliance with regulatory guidelines, such as 21 CFR 880.5725, ensures proper maintenance and reduces risks.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Animas Model IR1250 underwent a traditional 510(k) clearance process through the FDA, with a decision date of December 10, 2004. The submission was classified as substantially equivalent (SESE) under the General Hospital advisory committee (HO) and was filed under product code LZG. The clearance number is K042873, and the device is categorized as a Class II medical device.