True Metrix Glucose Meter Warning Issued Over Error Code, Patient Death: FDA

Manufacturer is updating device instructions after more than 100 serious injuries resulting from a failure to advise users to seek immediate medical care.

Federal health officials are warning that certain True Metrix blood glucose meters may lack instructions to seek immediate medical attention when specific error messages appear in conjunction with high blood glucose symptoms.

The U.S. Food and Drug Administration (FDA) announced the True Metrix glucose monitoring system correction on February 6, indicating a need to update instructions after at least 114 serious injuries and one death were reported in connection with the issue.

True Metrix glucose meters are used by people with diabetes to measure and monitor blood sugar levels by pricking a finger to obtain a small blood sample. 

However, officials warn that an E-5 error code can appear during a severe hyperglycemic event or due to a test strip error, preventing the meter from displaying a usable reading and failing to alert users that they should seek immediate medical care. Without that guidance, users may delay treatment during a medical emergency, increasing the risk of serious injury or death.

While the True Metrix system differs from continuous glucose monitors (CGMs), which use sensors placed under the skin to track glucose levels in real time, federal regulators have raised similar safety concerns across diabetes devices in recent months

Last week, the U.S. Food and Drug Administration (FDA) announced a FreeStyle Libre 3 CGM sensor recall of approximately 3 million devices, warning the sensors may display falsely low or incorrect blood glucose values, potentially leading users to delay treatment or take inappropriate corrective action during dangerous blood sugar events.

With more than 850 reports of serious adverse events worldwide tied to the defective FreeStyle sensors, including 7 deaths, FreeStyle Libre 3 recall lawsuits are now being filed against Abbott over the manufacturer’s alleged failure to ensure accurate glucose readings.

True Metrix Glucose Meter Warning

Although the correction applies to all True Metrix, True Metrix Air, True Metrix Go and True Metrix Pro blood glucose monitoring systems, the devices may continue to be used with updated instructions.

Trividia Health Inc., the manufacturer of True Metrix, has revised its Owner’s Booklets and Instructions for Use to clearly advise users to seek immediate medical attention if an E-5 error code appears while experiencing symptoms of high blood glucose, including fatigue, excessive urination, thirst or blurred vision.

The company is notifying affected customers through a Product Notice that outlines required actions, requests that the notice be posted at storage or retail locations, and instructs recipients to forward the information to all device users.

For more information, users can contact the Trividia Health Customer Care Department at 1-888-835-2723 Monday through Friday from 8 a.m. to 8 p.m. EST, email trividia0126CC@trividiahealth.com, or visit www.trividiahealth.com/E-5productnotice.

Adverse reactions may also be reported to the FDA’s Adverse Event Reporting program, online at MedWatch, or by calling 1- 800-332-1088 to request a reporting form or else downloading it from the website and returning it by fax to 1-800-FDA-0178 or to the address on the form.

FreeStyle Libre 3 Lawsuits

Following hundreds of adverse events related to recalled Abbott FreeStyle Libre 3 continuous glucose monitor systems, attorneys across the country are investigating potential product liability lawsuits on behalf of individuals and families who suffered  injuries allegedly caused by the devices’ inaccurate glucose readings.

Individuals may qualify for a Libre 3 recall lawsuit if they or a loved one used a recalled FreeStyle Libre 3 or Libre 3 Plus sensor and suffered serious injuries after relying on inaccurate glucose readings, including:

• Wrongful Death
• Severe hypoglycemia
• Seizures
• Confusion or altered mental state
• Loss of consciousness
• Diabetic ketoacidosis
• Other acute metabolic emergencies
• Emergency medical treatment or hospitalization

To determine whether you or a family member may qualify for a FreeStyle Libre 3 lawsuit, submit your information for a free case evaluation. An attorney can review the case, explain your legal rights and pursue a claim if eligible.

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