LifeScan UK/Ireland, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4DP Tel: 01494 658 750 Fax: 01494 658 751 www.LifeScan.co.uk
Customer Care Freephone: UK 0800 121200 IRELAND 1800 535676

Urgent Field Safety Notice

OneTouch® Verio®IQ Blood Glucose Meter
OneTouch® Verio®Pro Blood Glucose Meter

March 25, 2013

OneTouch® Verio®IQ Blood Glucose Meter

Dear Valued Customer:

If you use, recommend or sell the OneTouch®Verio®IQ Blood Glucose Meter, we want to make you aware that LifeScan is voluntarily replacing all OneTouch®Verio®IQ Blood Glucose Meters.

Failure To Provide A Warning At Extremely High Blood Glucose Levels

We have recently determined that at extremely high blood glucose levels of 56.8 mmol/L and above, the OneTouch® Verio®IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 33.3 mmol/L” as intended. When turned back on, the meter enters the Set-Up mode and requires the user to confirm the date and time settings before being able to test again. However, if the glucose level is still 56.8 mmol/L or above when testing, the meter will shut down again.

The likelihood of experiencing extremely high blood glucose levels of 56.8 mmol/L and above is rare. However, when they occur, they are a serious health risk and require immediate medical attention. As the OneTouch® Verio®IQ Meter does not provide the “EXTREME HIGH GLUCOSE above 33.3 mmol/L” message at glucose levels of 56.8 mmol/L and above, there may be a delay in the diagnosis and treatment of extreme hyperglycemia or incorrect treatment may be given. This could lead to serious injury. As a result, we have decided to replace all OneTouch® Verio®IQ Meters at no charge.

In Order To Receive Replacement Meters At No Charge, Please Follow The Steps Below:

People with Diabetes: Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to verify your OneTouch®Verio®IQ Meter Serial Number and confirm your address so that we may send you a replacement meter. You can continue to test with your current OneTouch® Verio®IQ Meter while you wait for your replacement meter to arrive. However, If your OneTouch® Verio®IQ Meter unexpectedly turns off and enters set-up mode after turning it back on, your blood glucose may be extremely high, and you should call your health care professional. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional. Please print and keep this notice with your Owner’s Booklet.

Healthcare Professionals: Discontinue distributing OneTouch®Verio®IQ Meters to patients and collect and hold all OneTouch®Verio®IQ Meter samples. A LifeScan sales representative will contact you in the near future to arrange for pick up and replacement. You may also call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) for assistance. While LifeScan will be notifying patients directly, we also request your assistance in sharing this information with your patients who use the OneTouch®Verio®IQ Meter. Patients can continue to test with their OneTouch® Verio®IQ Meter while they wait for their replacement meter to arrive as long as they are aware of this issue and know how to respond. Please refer any patients with OneTouch®Verio®IQ Meter to LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter at no charge.

Pharmacists: Identify and return all OneTouch®Verio®IQ Meters you have in inventory for a credit following your normal return procedures.
While LifeScan will be notifying patients directly, we also request your assistance in sharing this information with your patients who use the OneTouch®Verio®IQ Meter. Patients can continue to test with their OneTouch® Verio®IQ Meter while they wait for their replacement meter to arrive as long as they are aware of this issue and know how to respond. Please refer any patients with OneTouch®Verio®IQ Meters to LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter at no charge.

Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) if you have questions about this action.

Distributors: Identify and hold all OneTouch®Verio®IQ Meters you have in inventory.

Communicate this replacement program to your customers that purchased OneTouch®Verio®IQ Meters from you. Request that they return only OneTouch®Verio®IQ Meters per your normal return procedures. Once you have received all OneTouch®Verio®IQ Meters to be returned, call 0800 279 9118 (UK) or 1800 535 676 (Ireland) for a returned goods authorisation (RGA) and product return instructions.

The OneTouch products included in this Field Safety Corrective Action are the OneTouch®Verio®Pro blood glucose meter, the OneTouch® Verio®IQ blood glucose meter, and the OneTouch®Verio®Pro+ blood glucose meter. All other OneTouch® brand products, including OneTouch® Ultra® blood glucose meters, OneTouch® Vita® blood glucose monitors and OneTouch® Verio® test strips, are not affected and can continue to be used with confidence.

We remain committed to providing you with the highest quality products and services, and apologise for any inconvenience this issue may cause. Thank you for your continued support of LifeScan.

Sincerely,

LifeScan Customer Service

 

OneTouch® Verio®Pro

Dear Valued Customer:

If you use or recommend the OneTouch®Verio®Pro Blood Glucose Meter, we want to make you aware that LifeScan is voluntarily removing and replacing all OneTouch®Verio®Pro Blood Glucose Meters.

Incorrect Test Results At Extremely High Blood Glucose Levels

At blood glucose levels of 33.3 mmol/L and above, the OneTouch®Verio®Pro Meter should display a warning that says “EXTREME HIGH BG above 33.3 mmol/L.” We have recently determined that at extremely high blood glucose levels of 56.8 mmol/L and above, the OneTouch®Verio®Pro Meter will display and store in memory an incorrect test result that is 56.8 mmol/L below the measured result

Example: a blood glucose value of 59.1 mmol/L would result in the following: 59.1 mmol/L –56.8 mmol/L = 2.3 mmol/L. The meter would display 2.3 mmol/L and store 2.3 mmol/L in the log.

The likelihood of experiencing extremely high blood glucose levels 56.8 mmol/L and above is rare. However, when they occur, they are a serious health risk and require immediate medical attention. As the OneTouch®Verio®Pro Meter does not provide a warning at blood glucose levels of 56.8mmol/L and above and displays an inaccurate low result, there may be a delay in the diagnosis and treatment of severe hyperglycemia, or incorrect treatment may be given. This could lead to serious injury. As a result, we have decided to remove and replace all OneTouch®Verio®Pro Meters at no charge

Patients should discontinue use of this meter immediately and use another meter for testing their blood glucose.

Extreme hyperglycemia requires immediate medical attention. If patients ever experience symptoms that are not consistent with their blood glucose results, they should call their health care professional. They should never ignore symptoms or make significant changes to their diabetes management program without speaking to their health care professional.

In Order To Receive Replacement Meters At No Charge, Please Follow The Steps Below:

People with Diabetes: Discontinue use of your OneTouch®Verio®Pro Meter immediately and use another method for testing your blood glucose. Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to verify your OneTouch®Verio®Pro Meter Serial Number and confirm your address so that we may send you a replacement meter.

Healthcare Professionals: Discontinue distributing OneTouch®Verio®Pro Meters to patients and collect and hold all OneTouch®Verio®Pro Meter samples. A LifeScan sales representative will contact you in the near future to arrange for pick up and replacement.You may also call LifeScan Customer Service at 0800 121 200 (UK) 1800 535 676 (Ireland) for assistance. While LifeScan will be notifying patients directly, we also request your assistance in sharing this information with your patients who use the OneTouch®Verio®Pro Meter. Please refer any patients with OneTouch®Verio®Pro Meter to LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter.

Pharmacists: While LifeScan will be notifying patients directly, we also request your assistance in sharing this information with your patients who use the OneTouch®Verio®Pro Meter. Please refer any patients with OneTouch®Verio®Pro Meters to LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter

Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) if you have questions about this action.

The OneTouch products included in this Field Safety Corrective Action are the OneTouch®Verio®Pro blood glucose meter, the OneTouch® Verio®IQ blood glucose meter, and the OneTouch®Verio®Pro+ blood glucose meter. All other OneTouch® brand products, including OneTouch® Ultra® blood glucose meters, OneTouch® Vita® blood glucose monitors and OneTouch® Verio® test strips, are not affected and can continue to be used with confidence.

We remain committed to providing you with the highest quality products and services, and apologise for any inconvenience this issue may cause. Thank you for your continued support of LifeScan.

Sincerely,

LifeScan Customer Service