2 days ago
Diabetes Warning Issued Over Insulin Pump Error
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
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A medical device manufacturer has issued an urgent correction for select insulin pumps due to a possible error that could result in insulin not being delivered, the U.S. Food and Drug Administration (FDA) announced.
Tandem Diabetes Care, Inc., based in California, said the error appears as a Malfunction 16 alarm to users, and may stop insulin delivery. It can also halt communication between the insulin pump and the continuous glucose monitoring (CGM) device.
Newsweek contacted Tandem Diabetes Care, Inc. for comment by email outside of regular working hours.
Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered.
Stock image. Tandem Diabetes Care, Inc. has issued a correction for select insulin pumps due to a possible error that could result in insulin not being delivered.
Jens Kalaene/picture-alliance/dpa/AP
Why It Matters
The FDA said that if the error is not addressed it could lead to hyperglycemia - high blood sugar - in users due to insulin not being delivered.
"In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional," it said.
Hyperglycemia symptoms include extreme thirst, blurry vision, weakness, dry mouth, headaches, and frequent urination, according to the Centers for Disease Control and Prevention.
What To Know
The device affected by the urgent correction is the following: t:slim X2 insulin pumps.
As of August 12, there had been 700 confirmed adverse events - incidents of confirmed high blood sugar or an event requiring medical intervention - and 59 reported injuries related to the device error, according to the FDA. No deaths had been reported.
The FDA said that notices were sent directly to customers across the U.S. between July 22 and 24 with instructions on what to do in the event of a Malfunction 16 alarm.
The company is set to release a software update to boost early detection of speaker failures, according to the FDA. The update will also introduce persistent vibration alerts to reduce potential safety risks.
What People Are Saying
Tandem Diabetes Care, Inc. said in its urgent medical device correction notice: "A Malfunction 16 will stop insulin delivery and terminate communication between the insulin pump and the CGM device, as well as the Tandem t:slim mobile app. If not addressed, this could result in hyperglycemia due to the malfunction resulting in the stoppage of insulin delivery and real time CGM Estimated Glucose Values (EGVs) and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional.
"Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax."
What Happens Next
The company will notify affected pump users when the software update is available and request that the update is completed.
Users who have concerns about their pumps can contact the company on techsupport@ or call 1-877-801-6901.
