This message was posted on the other forum I am on - thought you might want to check if you have a OneTouch Ultrasmart meter.🙂Bev
February XX, 2010 Urgent: Field Safety Notice
Affecting Certain OneTouch? UltraSmart?
Blood Glucose Monitors
Dear Valued Customer:
I am writing you because our records show that you recently received a OneTouch? UltraSmart Blood Glucose Monitor. We want to make you aware of the following:
The Issue: Certain OneTouch UltraSmart Meters are set to the incorrect unit of measure
We have recently determined that a small number of OneTouch UltraSmart meters were incorrectly set to provide readings in milligrams per decilitre (mg/dL) instead of the standard unit of measure in the UK, which is millimoles per litre (mmol/L).
Test results expressed in mg/dL do not contain a decimal point and are 18 times higher than the same results expressed in mmol/L. For example, a result of "6.0 mmol/L" would display as "108 mg/dL," which might be misinterpreted as "10.8 mmol/L." This could potentially result in a user making inappropriate treatment decisions.
Although this issue affects a very small number of meters in the UK, our records indicate that you received one of the impacted meters. Therefore we have enclosed a replacement OneTouch UltraSmart meter for you, which is set to the correct unit of measure. We have also enclosed a pre-paid envelope and ask that you return the original meter to us in this envelope.
Please contact LifeScan Customer Care at 0800 121200 to confirm you received this notice.
We take this issue very seriously and are taking steps to prevent it from recurring in the future. In addition, we have notified the Medicines and Healthcare Products Regulatory Agency of this issue and the steps we are taking to address it.
We apologize for any inconvenience this may cause. For questions or additional information, please contact OneTouch Customer Care on 0800 121200. We are available between the hours of 8.30am – 6pm Monday to Friday and 9am to 1pm on Saturday. Thank you for your continued support of LifeScan.
February XX, 2010 Urgent: Field Safety Notice
Affecting Certain OneTouch? UltraSmart?
Blood Glucose Monitors
Dear Valued Customer:
I am writing you because our records show that you recently received a OneTouch? UltraSmart Blood Glucose Monitor. We want to make you aware of the following:
The Issue: Certain OneTouch UltraSmart Meters are set to the incorrect unit of measure
We have recently determined that a small number of OneTouch UltraSmart meters were incorrectly set to provide readings in milligrams per decilitre (mg/dL) instead of the standard unit of measure in the UK, which is millimoles per litre (mmol/L).
Test results expressed in mg/dL do not contain a decimal point and are 18 times higher than the same results expressed in mmol/L. For example, a result of "6.0 mmol/L" would display as "108 mg/dL," which might be misinterpreted as "10.8 mmol/L." This could potentially result in a user making inappropriate treatment decisions.
Although this issue affects a very small number of meters in the UK, our records indicate that you received one of the impacted meters. Therefore we have enclosed a replacement OneTouch UltraSmart meter for you, which is set to the correct unit of measure. We have also enclosed a pre-paid envelope and ask that you return the original meter to us in this envelope.
Please contact LifeScan Customer Care at 0800 121200 to confirm you received this notice.
We take this issue very seriously and are taking steps to prevent it from recurring in the future. In addition, we have notified the Medicines and Healthcare Products Regulatory Agency of this issue and the steps we are taking to address it.
We apologize for any inconvenience this may cause. For questions or additional information, please contact OneTouch Customer Care on 0800 121200. We are available between the hours of 8.30am – 6pm Monday to Friday and 9am to 1pm on Saturday. Thank you for your continued support of LifeScan.