LifeScan, Inc. (LifeScan) a subsidiary of Johnson & Johnson (J&J), has notified the U.S. Food and Drug Administration (FDA) and healthcare authorities around the world, of a recall and replacement of its OneTouch VerioIQ Meters because of a defect involving the improper reading of extremely high blood glucose levels. Officials with LifeScan are working with the individual regulatory agencies around the world where the affected products have been sold.
Of the 1.2 million LifeScan OneTouch VerioIQ Meters, recalled worldwide, 90,000 were sold in the U.S.
At extremely high blood glucose levels, specifically anything over 1024 mg/dL, the meter fails to display the standard warning message, “Extreme high glucose above 600 mg/dL,” and, instead, automatically shuts off. When it is turned back on, it returns to the Set-up mode and requires the user to confirm the date and time settings before being able to test again.
As no explanation accompanies the shut-down, a diabetic with dangerously high blood glucose levels could be left completely unaware of the seriousness of the situation, mistakenly assuming that the device shut off accidently or for some other small reason.
J&J states that such extreme blood glucose levels are “remote.” However, this is all the more reason why it is critical for a diabetic with these levels to be aware of the seriousness of the situation and to seek immediate medical attention.
LifeScan stated in a press release, that “[b]ecause [the OneTouch Verio IQ meters] do not provide an appropriate warning…diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality.”
“Our patients’ safety is our number one priority,” said Dr. Michael Pfeifer, LifeScan’s Chief Medical Officer. “When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients.”
Notification of the recall is being sent to all registered users of the product, healthcare professionals, pharmacies, and distributors. LifeScan is directing users to call 1-800-717-0276 to receive a free replacement meter. Officials state that the product may continue to be used until the replacement arrives, as long as the diabetic understands the circumstances of the defect and is extremely vigilant. If the meter does shut off, it is possible that the individual’s blood glucose levels are dangerously high.
At this time, no patient injuries related to the malfunction of the LifeScan OneTouch VerioIQ Meter have been reported in the U.S. But, at least one incident involving a different model, the OneTouch VerioPro, has been reported outside of the U.S. A link between that meter and the injury has yet to be confirmed.
If you or a loved one has experienced complications from use of a LifeScan OTVIQ, you may be entitled to legal remedies. The attorneys of McEldrew Law have decades of success, litigating complex personal injury matters, related to product defects and medical device malfunction. Moreover, to assist with your case, the staff of McEldrew Law includes a pharmaceutical diabetic engineer, formerly the in-house engineer for a major pharmaceutical company. Our collective experience, knowledge, and expertise has resulted in a national reputation for excellence and results. For a free and confidential consultation, contact McEldrew Law at (800) 223-3352 or jim@mceldrewlaw.com or complete the online form here.
LifeScan Recalls Defective Blood Glucose Meters
Posted by advocateadmin in News
Of the 1.2 million LifeScan OneTouch VerioIQ Meters, recalled worldwide, 90,000 were sold in the U.S.
At extremely high blood glucose levels, specifically anything over 1024 mg/dL, the meter fails to display the standard warning message, “Extreme high glucose above 600 mg/dL,” and, instead, automatically shuts off. When it is turned back on, it returns to the Set-up mode and requires the user to confirm the date and time settings before being able to test again.
As no explanation accompanies the shut-down, a diabetic with dangerously high blood glucose levels could be left completely unaware of the seriousness of the situation, mistakenly assuming that the device shut off accidently or for some other small reason.
J&J states that such extreme blood glucose levels are “remote.” However, this is all the more reason why it is critical for a diabetic with these levels to be aware of the seriousness of the situation and to seek immediate medical attention.
LifeScan stated in a press release, that “[b]ecause [the OneTouch Verio IQ meters] do not provide an appropriate warning…diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality.”
“Our patients’ safety is our number one priority,” said Dr. Michael Pfeifer, LifeScan’s Chief Medical Officer. “When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients.”
Notification of the recall is being sent to all registered users of the product, healthcare professionals, pharmacies, and distributors. LifeScan is directing users to call 1-800-717-0276 to receive a free replacement meter. Officials state that the product may continue to be used until the replacement arrives, as long as the diabetic understands the circumstances of the defect and is extremely vigilant. If the meter does shut off, it is possible that the individual’s blood glucose levels are dangerously high.
At this time, no patient injuries related to the malfunction of the LifeScan OneTouch VerioIQ Meter have been reported in the U.S. But, at least one incident involving a different model, the OneTouch VerioPro, has been reported outside of the U.S. A link between that meter and the injury has yet to be confirmed.
If you or a loved one has experienced complications from use of a LifeScan OTVIQ, you may be entitled to legal remedies. The attorneys of McEldrew Law have decades of success, litigating complex personal injury matters, related to product defects and medical device malfunction. Moreover, to assist with your case, the staff of McEldrew Law includes a pharmaceutical diabetic engineer, formerly the in-house engineer for a major pharmaceutical company. Our collective experience, knowledge, and expertise has resulted in a national reputation for excellence and results. For a free and confidential consultation, contact McEldrew Law at (800) 223-3352 or jim@mceldrewlaw.com or complete the online form here.