TRUE METRIX Blood Glucose Monitor Early E-5 Error Injury Lawsuit Lawyers

FDA flags potential high-risk issue after Trividia Health reports injuries and updates safety instructions for millions of glucose monitoring devices

Continuous blood glucose monitoring and testing devices play a central role in diabetes management for millions of Americans. Patients depend on these systems to guide insulin dosing, dietary choices, and emergency responses to high or low blood sugar levels. When a glucose meter provides confusing or misleading information, the consequences can quickly become dangerous.

The U.S. Food and Drug Administration has issued an Early Alert regarding certain TRUE METRIX blood glucose monitoring systems manufactured by Trividia Health, Inc. The agency is warning the public about a potentially high-risk device issue involving updated instructions tied to the E-5 error code. According to the FDA, the existing instructions could lead to delayed medical care in situations involving dangerously high blood sugar.

What Parker Waichman LLP Found

Our legal team is closely reviewing the TRUE METRIX Early Alert and related injury reports. Key takeaways include:

• The E-5 error code may create confusion between strip errors and dangerous hyperglycemia.
• The FDA warned that earlier instructions could delay life-saving treatment.
• More than 100 serious injuries have already been reported.
• Labeling changes suggest prior warnings may have been insufficient.
• Patients who suffered harm after relying on TRUE METRIX devices may have grounds to pursue compensation.

Parker Waichman LLP is investigating potential claims related to TRUE METRIX blood glucose monitor complications. Individuals who suffered medical emergencies, injuries, or other harm after relying on these devices may have legal rights to pursue financial recovery. Victims can call us by dialing 1-800-968-7529 to receive a free consultation.

Understanding the FDA Early Alert

The FDA’s Center for Devices and Radiological Health issued the Early Alert to inform the public of a safety concern that could pose serious health risks. Unlike a full recall, an Early Alert signals that regulators are actively reviewing a potentially dangerous device issue while additional information is gathered.

In this situation, Trividia Health issued an Urgent Medical Device Correction affecting multiple TRUE METRIX blood glucose monitoring systems. Rather than removing products from the market, the company updated the device instructions, particularly those addressing the E-5 error code.

Regulators warned that the prior instructions may not have adequately emphasized the need for immediate medical attention when users experience symptoms of very high blood glucose alongside the E-5 message. Because timely treatment is critical during severe hyperglycemia events, any delay could result in serious complications.

The FDA has stated it will continue monitoring the situation and update the public as new information becomes available.

Which TRUE METRIX Devices Are Affected

The correction applies broadly across the TRUE METRIX product line used by both patients and healthcare professionals. Affected systems include:

• TRUE METRIX Self-Monitoring Blood Glucose System
• TRUE METRIX AIR Self-Monitoring Blood Glucose System
• TRUE METRIX GO Self-Monitoring Blood Glucose System
• TRUE METRIX PRO Professional Monitoring Blood Glucose System

These devices are widely used to measure glucose levels in fresh whole blood samples. Because of their broad distribution and routine use in diabetes care, any safety concern has the potential to affect a large number of patients nationwide.

Importantly, Trividia has stated that the products may continue to be used and do not need to be returned or replaced. However, the updated instructions are considered critical for safe operation.

The E-5 Error Code: Why It Matters

The central concern involves the E-5 error code displayed by TRUE METRIX devices. According to the updated guidance, this code can indicate either:

• Very high blood glucose levels above 600 mg/dL, or
• A test strip error

Because the same error code can represent two very different situations, there is a risk that some users may misinterpret the message and delay necessary medical care.

The revised instructions now emphasize the following steps:

• Retest using a new test strip
• If symptoms of high glucose are present, seek immediate medical attention
• If no symptoms are present but the error persists, contact customer support

The FDA noted that earlier instructions may not have sufficiently stressed the urgency of seeking medical care when symptoms are present.

Reported Injuries and Death

As of January 16, Trividia Health reported:

• 114 serious injuries
• 1 reported death

linked to the issue under review.

These reports highlight why even labeling corrections can carry significant medical and legal implications. Severe hyperglycemia can lead to dehydration, confusion, diabetic ketoacidosis, coma, or death if not treated promptly.

When a medical device’s instructions contribute to delayed treatment, regulators and product liability attorneys often examine whether warnings were adequate and timely.

Health Risks Associated With Delayed Treatment

When blood glucose rises above safe levels, the body can quickly enter a dangerous state. Potential complications include:

• Severe dehydration
• Altered mental status
• Diabetic ketoacidosis
• Emergency hospitalization
• Long-term organ damage
• Death in extreme cases

Patients experiencing symptoms such as excessive thirst, frequent urination, fatigue, or blurred vision must act quickly. Any confusion created by device messaging can increase the risk of serious harm.

For insulin-dependent patients, children, and older adults, the margin for error can be especially narrow.

Legal Rights of Injured Patients

When a medical device contributes to injury, patients may have the right to pursue a product liability claim. These cases often focus on whether the manufacturer:

• Failed to provide adequate warnings
• Provided unclear or misleading instructions
• Failed to properly test the device
• Failed to act promptly after identifying risks

Even when a product is not formally recalled, companies can still be held accountable if their labeling or design contributes to preventable harm.

Each case depends on specific medical records, device data, and timing of events.

Steps Patients Should Take If They Experienced Problems

Individuals who encountered an E-5 error and later experienced a medical emergency should consider taking the following steps:

• Seek appropriate medical evaluation and follow-up care
• Preserve the glucose meter, packaging, and test strips if available
• Document symptoms and treatment received
• Save hospital and pharmacy records
• Report adverse events through the FDA MedWatch program

Early documentation can be important if a legal claim is pursued.

TRUE METRIX Lawsuit FAQs

What is the main safety concern with TRUE METRIX glucose meters?
The concern centers on the E-5 error code, which may indicate either extremely high blood sugar or a test strip problem. Regulators warned that earlier instructions may have caused some users to delay medical care during dangerous hyperglycemia events.

Do I need to stop using my TRUE METRIX device?
Current guidance states that patients may continue using the devices, but they must carefully follow the updated instructions. Anyone experiencing symptoms of very high blood glucose alongside an E-5 error should seek medical attention immediately.

Can I file a lawsuit if I was injured?
Possibly. Patients who suffered hospitalization, severe hyperglycemia, or related complications after relying on the device may have legal claims. Eligibility depends on medical evidence and the facts surrounding the incident.

What compensation may be available?
Depending on the case, compensation may include medical expenses, lost wages, pain and suffering, and future care costs. In fatal cases, surviving family members may pursue wrongful death damages where permitted by law.

Does the Early Alert mean the device is defective?
An Early Alert does not automatically prove a defect. However, it signals that regulators have identified a potentially serious safety concern. Such findings can become important evidence in product liability litigation.

How long do I have to file a claim?
Filing deadlines vary by state. Because medical device claims are time-sensitive, speaking with an attorney promptly helps protect your legal rights.

Why Prompt Legal Review Matters

Medical device cases often involve complex technical evidence, including device logs, labeling history, and regulatory communications. Waiting too long can make it harder to preserve key evidence and meet filing deadlines.

Because the FDA continues to evaluate this issue, additional developments may emerge. Patients who experienced complications should consider having their situation reviewed sooner rather than later.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

Parker Waichman LLP is actively investigating potential claims involving TRUE METRIX blood glucose monitoring systems. Our national product liability attorneys represent individuals and families harmed by defective or improperly labeled medical devices.

If you or a loved one suffered a medical emergency after receiving an E-5 error or relying on a TRUE METRIX device, you may be entitled to monetary compensation.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free case review. There is no obligation, and you pay nothing unless we recover compensation for you. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.