Animas insulin pump recall
The Federal Drug Administration has assigned its most serious Class I tag to a recent recall of Johnson & Johnson’s Animas Infusion Insulin Pumps, saying the problem could lead to serious injury and death. J&J is recalling its 2020 devices, warning that a malfunction may lead to unintended insulin delivery, putting patients at a significant risk.
The Animas 2020 pumps, which are used to deliver insulin directly into the patient’s blood for the treatment of diabetes, have a faulty component that can lead to erroneous alarms. They also prompt patients to rewind, load and prime them, which can trigger unwanted infusion and put users at risk for hypoglycemia. In addition, the insulin pumps have a software glitch that will render them unusable on December 31, 2015. After this date, the pump will no longer deliver insulin, leading to the possibility of serious health consequences.
In January, Animas launched the recall of 384,000 pumps, which were distributed between March 1, 2012 and November 30, 2012. The FDA noted that all lots of the recalled product were involved. Customers were instructed to disconnect the device from their bodies before resetting it and to immediately contact the company for a replacement. They have also been told to follow the safety instructions in the Animas Owner’s Booklet and to speak to Animas’ Product Fulfillment Center at 1-877-280-2339 between 6:00 a.m. and 12:00 a.m., Eastern Standard Time, to schedule shipment of a free replacement pump.
The FDA has warned Animas that it could face fines and other sanctions for continuing to see defective insulin pumps and delaying the disclosure of serious injuries to patients. It has ordered them to provide an explanation for why they kept selling the pumps that were known to be faulty and to submit a plan that will promptly rectify its failure to report these injury cases, in which the pump may have contributed to serious injury or death. The patients referenced were hospitalized with dangerously high blood sugar, respiratory failure and coma, and the life-threatening complication diabetic ketoacidosis, which is cause by lack of insulin to break down blood sugar. The FDA is asking customers to report any health problems that may possibly be related to use of the Animas insulin pump through its online MedWatch system.
This is the second recall for J&J in recent months. The company was also forced to remove the LifeScan OneTouch VerioIQ devices from shelves. These faulty meters fail to alert patients with dangerously high blood sugar levels, resulting in at least one death.
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OneTouch Verio IQ Recall
OneTouch® Verio®IQ Meter Recall
OneTouch® Verio®IQ
On March 25, 2013, LifeScan, Inc. (“LifeScan”), a subsidiary of Johnson & Johnson “J&J”), recalled nearly two million OneTouch® Verio®IQ (“OTVIQ”) blood glucose meters due to a product defect, which creates a substantial risk of severe health hazards. After detecting extremely high blood glucose levels of 1024 mg/dl or higher, the OTVIQ inexplicitly shuts down and fails to provide the user with an adequate reading and warning. As a result, a hyperglycemic patient may inadvertently fail to inject themselves with insulin or seek immediate medical attention, which poses serious, even fatal, health risks.
Of course, for diabetic patients, accurate blood glucose testing can mean the difference between life and death. As blood sugar levels rise, patients may experience severe complications, such as cell and blood vessel damage, vision problems, and organ failure, which in turn, can result in blindness, ketoacidosis, even death. Due to the severity of their condition, it is absolutely imperative that diabetics can trust in the quality of products like the OTVIQ.
LifeScan and J&J are currently defendants in a Louisiana based wrongful death action, based on a comparable failure of a similar product, the OneTouch® Ultra® Blood Glucose Meter (“OTUBGM”). The plaintiff, Lenora Cousin, alleges her diabetic husband mistakenly overdosed on insulin, because of an inaccurate reading from his OTUBGM. While the erroneous reading of Mr. Cousin’s LifeScan meter resulted in too much insulin, as opposed to not enough insulin (the risk related to the current recall), it demonstrates the significant danger to diabetic patients of defective blood glucose meters.
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.
Read MoreWorldwide Recalls of LifeScan OneTouch Meter
OneTouch® Verio®IQ
In addition to 90,000 of its OneTouch VerioIQ (VerioIQ) blood glucose meters sold in the U.S., LifeScan, Inc. (LifeScan) a subsidiary of Johnson & Johnson (J&J), is recalling two other models sold in international markets. Over 670,000 OneTouch VerioPro Meters (VerioPro) were recalled in Europe, as well as, 4,900 OneTouch VerioPro + Meters (VerioPro +) used in hospitals and clinics outside the U.S.
Each model malfunctions in a slightly different manner. The VerioIQ automatically shuts off at blood glucose levels of 1024 mg/dL or higher. The VerioPro displays and stores an incorrect reading, which is the actual blood glucose level minus 1024 mg/dL. Finally, the VerioPro + correctly displays the warning message, but stores an incorrect reading – again, the actual blood glucose level minus 1024 mg/dL. While patients in the US have been informed that they may continue to use their current meters, provided they are aware of the defect, those outside of the country have been told to stop using OneTouch VerioPro meters immediately.
Additionally, while no reports of patient injury have been verified in the U.S., one incident has been linked to the VerioPro. But, it has not yet been determined whether there is a causal relationship between the two.
All other OneTouch blood glucose brands sold in the U.S., including OneTouch Ultra Meters, OneTouch Select Meters and OneTouch Verio Test Strips, are not affected.
The recall of the various LifeScan OneTouch blood glucose meters is the latest of close to three dozen recalls since 2009 by J&J, the world’s biggest provider of health care products.
Most of these recalls involved nonprescription medications, such as Infants’ Tylenol. But, others include faulty hip replacements and prescription drugs. The reasons for the recalls of varied, from inaccurate levels of active ingredients in medicines, the presence of glass or metal shards in liquid medicines, to nauseating packaging smells.
In response to increased FDA scrutiny, J&J is completely rebuilding one nonprescription medicine factory from the ground up and upgrading numerous other facilities.
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.
Read MoreLifeScan Recalls Defective Blood Glucose Meters
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.
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