By Robin Foster HealthDay Reporter
FRIDAY, July 26, 2024 — Abbott has warned diabetes sufferers that a few of its steady blood sugar monitoring methods could have to be changed due to inaccurate readings.
“Abbott has just lately recognized a small variety of FreeStyle Libre 3 sensors that will present incorrect excessive glucose readings, which if undetected could pose a possible well being danger for individuals dwelling with diabetes,” the corporate stated in an alert issued Thursday.
An inaccurate excessive blood sugar studying could immediate diabetes sufferers to take insulin once they don’t want it, the corporate stated. That may set off hypoglycemia (low blood sugar), a situation that may grow to be life-threatening if not acknowledged or addressed, in accordance with the Mayo Clinic.
Lower than 1% of American customers of the Libre 3 sensors are affected, with the affected units being distributed within the first half of Might, the corporate stated.
Abbott added that it’s going to exchange the sensors at no cost. The corporate stated individuals ought to test the corporate’s to substantiate whether or not their sensor is affected after which notify the corporate so a alternative sensor will be despatched to their dwelling. The sensors got here from these three lot numbers, in accordance with Abbott: T60001948, T60001966, T60001969.
Any antagonistic reactions with using these sensors ought to be reported to Abbott’s customer support line at 1-833-815-4273, the corporate stated.
Such studies may be despatched to the FDA’s MedWatch Adversarial Occasion Reporting program by finishing Type FDA 3500 on-line at www.FDA.gov, calling 1-800-FDA-1088 or faxing to 1-800-FDA-0178, Abbott added.
A steady glucose monitoring system makes use of a sensor, a reader and an app to assist individuals with diabetes test their blood sugar with out having to attract blood from their fingers. The U.S. Meals and Drug Administration first the Abbott units in 2017.
Sources
- Abbott, information launch, July 24, 2024
Disclaimer: Statistical knowledge in medical articles present basic tendencies and don’t pertain to people. Particular person elements can differ drastically. All the time search personalised medical recommendation for particular person healthcare choices.
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Posted July 2024
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