Johnson & Johnson is recalling all its OneTouch VerioIQ blood glucose meters in Canada and the U.S. because they do not provide a warning when a diabetic’s blood sugar level is dangerously high. Instead, at a certain sugar level, the meters turn off.
The meters are made by J&J’s LifeScan unit, which will issue a free replacement meter to all patients.
The company says the meters shut down when a patient’s blood sugar hits 1,024 milligrams per decilitre. That’s an extremely high level requiring immediate medical attention.
It’s extremely unlikely that a diabetic’s blood sugar level would get that high. However, if a patient experienced such extreme high blood sugar and did not get prompt treatment or got an incorrect treatment based on a false meter reading, that could result in a serious health risk or death, according to J&J.
Burnaby, B.C.-based LifeScan Inc. estimates that there are approximately 60,000 active OneTouch VerioIQ meter users in Canada but said no adverse events or patient injuries related to this specific issue have been reported in Canada.
People with diabetes are encouraged to keep their peak blood sugar level, shortly after a meal, at or below 160 milligrams per decilitre.
When blood sugar gets even a little above that level, over time the excess sugar can damage blood vessels, the heart, kidneys, eyes and other organs, eventually resulting in severe complications such as blindness, kidney failure, leg amputations and premature death. Extremely high, sudden spikes can cause death if not treated aggressively.
Canadian users can contact LifeScan Customer Service at 855-293-5075 to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 9 a.m. to 8 p.m. EST Monday through Friday.
In the U.S. Johnson & Johnson, based in New Brunswick, N.J., said patients with one of the meters should contact LifeScan’s customer service at 800-717-0276 to arrange for a replacement meter or ask questions. Representatives are available from 8 a.m. to 10 p.m. EDT Monday through Sunday.
The recall is J&J’s latest in a string of about three dozen since 2009 by Johnson & Johnson, the world’s biggest provider of health care products.
Most have involved nonprescription medicines such as adult and children’s Tylenol and Motrin, but other recalls were for faulty hip replacements and prescription drugs for conditions such as epilepsy or for contact lenses. Reasons have included wrong levels of active ingredients in medicines, glass or metal shards in liquid medicines and nauseating packaging smells.
The company is operating under increased scrutiny from the U.S. Food and Drug Administration, while it completely rebuilds one nonprescription medicine factory from the ground up and upgrades other factories. The recalls and lost product sales have cost J&J well over $1 billion.Report Typo/Error