OneTouch Verio Pro and OneTouch Verio IQ Blood Glucose Meters 에 대한 현장 안전성 서한

Field Safety Notice

SN201304

2013-04-15

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/onetouch-verio-pro-and-onetouch-verio-iq-blood-glucose-meters&id=d97bf825-9782-6eee-9b55-ff00008c97d0

Lifescan has identified that the onetouch verio pro and onetouch verio iq blood glucose meters will not perform as expected at blood glucose levels of 56.8 mmol/l and above. lifescan is recalling and replacing all onetouch verio pro and verio iq blood glucose meters.

Immediate actions users should take:  Users of OneTouch Verio Pro  1. Discontinue use of these meters and use another method for testing their blood glucose.  2. Contact LifeScan Customer Service at +44 800 279 9118 (UK) or 1800 535 676 (Ireland) to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative.  3. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.  Users of OneTouch Verio IQ  1. Contact LifeScan Customer Service at +44 800 279 9118 (UK) or 1800 535 676 (Ireland) to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative  2. You can continue to test with your current OneTouch® Verio®IQ Meter while you wait for your replacement meter to arrive. However, if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention. 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.  3. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.  Actions for Pharmacists:  1. Identify and hold all OneTouch Verio Pro and Verio IQ Meters you have in inventory.  2. Return all OneTouch Verio Pro and Verio IQ Meters to the manufacturer.  3. Please share this information with patients who use the OneTouch Verio Pro and Verio IQ Meter.  4. Please refer any patients with OneTouch Verio Pro and Verio IQ Meters to LifeScan Customer Service at +44 800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter at no charge.  Actions for Healthcare Professionals:  1. Discontinue distributing OneTouch Verio Pro and Verio IQ Meters to patients and collect and hold all OneTouch Verio Pro and Verio IQ Meters 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 +44 800 279 9118 (UK) or 1800 535 676 (Ireland) for assistance.  2. Please share this information with your patients who use the OneTouch Verio Pro and Verio IQ Meters. Please refer any patients with OneTouch Verio Pro and Verio IQ Meters to LifeScan Customer Service at +44 800 279 9118 (UK) or 1800 535 676 (Ireland) to arrange to receive a replacement meter at no charge.  3. Please share this with other healthcare providers in your office who may be impacted by this notification.