Accu-Chek Spirit

• • Terminated Z-1734-2015 FDA Class II ·initiated 22 Apr 2015

  Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u

510(k) Number

K042887 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disetronic Rapid Subcutaneous Infusion Set and Disteronic Rapid D Subcutaneous Infusion Set

  Class II

  FDA 510(k) K003977 Active Cleared 15 Feb 2001

• Modification to D-Tronplus

  Class II

  FDA 510(k) K043000 Active Cleared 1 Dec 2004

• Modification to Disetronic D-Tronplus Insulin Infusion Pump

  Class II

  FDA 510(k) K022831 Active Cleared 11 Sep 2002

• Disetronic D-Modem

  Class II

  FDA 510(k) K943952 Active Cleared 7 Oct 1995

• Disetronic Pen

  Class II

  FDA 510(k) K982966 Active Cleared 19 Oct 1998

• Ultraflex Infusion Set

  Class II

  FDA 510(k) K033892 Active Cleared 9 Mar 2004

See all devices from Disetronic Medical Systems →

• What is the primary use of the Accu-Chek Spirit?

  The Accu-Chek Spirit is an infusion pump designed for the subcutaneous continuous delivery of insulin. It is intended for the management of diabetes mellitus in patients who require insulin therapy as prescribed by a physician.

• How does the Accu-Chek Spirit deliver insulin?

  The device provides both set and variable delivery rates to accommodate the specific insulin requirements of the patient as determined by their healthcare provider.

• What is the regulatory status of this infusion pump?

  The Accu-Chek Spirit is classified as a Class II insulin infusion pump under regulation number 880.5725. It received FDA 510(k) clearance on March 18, 2005, under submission number K042887.