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FDA Warning on J&J, LifeScan Inc. Blood Glucose Meters

May13, 2005

Background: According to a worldwide May 11, 2005, Food and Drug Administration (FDA) notification, it may be possible for diabetes patients using OneTouch® Ultra®, InDuo® and OneTouch® FastTake® Meters, manufactured by LifeScan Inc. (a Johnson & Johnson company), to misinterpret their blood glucose results. ;All three affected meter systems were designed to allow patients to select one of two units of measure to display their test results. However, the company said it found that it was possible for consumers, in the course of setting their meter's date and time, to accidentally change the unit of measure and thereby misinterpret their blood-glucose results. In addition, an event such as dropping a meter while in use could also cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips.

Basic Statement: Per FDA's Firm Safety Alert, allusers of these affected meter systems should continue to test their blood glucose. LifeScan, Inc., is instructing patients to confirm their meter's unit of measure and the code number each time they test.

Q&A

Should patients stop using their glucose meter immediately?
The FDA advises that all users should continue to test their blood glucose. However, patients with these products are advised to contact LifeScan, Inc.to confirm their meter's unit of measure and the code number each time they test it. Notifications will also be inserted in packages of test strips that are used with the devices.

How can patients contact LifeScan?
Patients can call LifeScan Customer Service at 1-800-515-0915.

What actions has LifeScan taken related to the FDA's announcement?
LifeScan has taken the following actions:

The company is conducting a worldwide notification program consisting of letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. The attached document is the pharmacist's letter developed by J&J Company, LifeScan Inc.

The company has temporarily stopped shipment of versions of the OneTouch® Ultra®, OneTouch® FastTake® and InDuo®Systems that allow users to change the unit of measure.

LifeScan, Inc., has implemented a product modification for its new OneTouch® Ultra® Meters that prevents users from inadvertently switching their meter's unit of measure. Shipments of theOneTouch® Ultra® Meters with this modification are expected to begin by May 20, 2005. However, the timing to resume shipments ofInDuo® and OneTouch® FastTake®Meters has not been determined.

Is the new modifiedOneTouch® Ultra® Meter available to CIGNA HealthCare members?
Yes. CIGNA Tel Drug has been using the new/modified OneTouch® Ultra® Metersince April 29, 2005.

What are CIGNA HealthCare preferred blood glucose meter products?
Following are CIGNA HealthCare preferred products:

  • Accu-Chek® Compact® System (modified meter)
  • SystemAccu-Chek Complete® System 
  • Accu-Chek® Active® System
  • Accu-ChekAdvantage® System
  • One Touch® Ultra® System
  • One Touch® Ultra Smart®

What actions has CIGNA HealthCare taken regarding this notification?
CIGNA HealthCare has taken the following actions:

Communication materialshave been distributed to our call centers to assist representatives in responding to member and provider inquiries.

Letters are being sent to members currently usingOneTouch® Ultra®, InDuo® and OneTouch® FastTake® Meters, advising them to contact LifeScan, Inc., to confirm their meter's unit of measure and the code number each time they test it.

Where can patients obtain additional information on these three meters?
You can obtain more information from LifeScan at:
  1. http://www.LifeScan.com, or
  2. LifeScan Customer Service at 1-800-515-091

More information on LifeScan glucose meters and the FDA's safety alert is available on the FDA's website at:
http://www.fda.gov/oc/po/firmrecalls/lifescan04_05.html

Contacts:
Christopher Warren, 358-1751


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