FDA flags two diabetes device problems: Omnipod under-delivery, TRUE METRIX E-5 risk

The FDA has flagged two diabetes device problems that can affect blood sugar safety: certain Omnipod pods may under-deliver insulin, and some TRUE METRIX glucose meters may display an E-5 error code that can mean different things.

For patients and caregivers, the practical step is the same in both cases: check whether the device is affected, keep monitoring glucose, and follow the manufacturer’s replacement or labeling instructions. Do not assume an alarm or error code tells the full story.

What the FDA announced and why it matters now

In spring 2026, the FDA posted safety updates for both devices. The Omnipod issue involves certain pods that may leak insulin inside the device instead of delivering it into the body. The TRUE METRIX issue involves how the meter’s E-5 code is explained in labeling, which can create confusion if the code appears during a very high glucose reading or because of a strip error.

Both issues matter because diabetes device problems can delay treatment, raise the risk of dangerous high blood sugar, or lead people to respond the wrong way to a reading or alarm.

Omnipod pod issue: what is affected, what can happen, and what to do

According to the FDA, certain Omnipod pods may have a small tear in the internal tubing that carries insulin. If that happens, insulin may leak inside the pod instead of being fully infused as intended, which can lead to under-delivery of insulin.

The FDA says the problem can sometimes trigger a hazard alarm, but it may also happen without any warning. That means a person could get less insulin than needed without realizing it. In severe cases, prolonged high blood sugar can lead to diabetic ketoacidosis, or DKA, which is a medical emergency.

The FDA says people should not use affected pods. If a person does not have enough replacement pods, they should talk with their health care provider about other methods of insulin delivery. The FDA also says to check lot numbers and replace an impacted pod as soon as possible if the one in use is from an affected lot.

As of the FDA’s April 30, 2026 update, Insulet had reported 29 serious injuries and no deaths related to the issue. The FDA also said the issue does not affect CGM systems or CGM readings.

TRUE METRIX issue: what the E-5 code can mean, who is most at risk, and what to do

The FDA says the TRUE METRIX correction affects TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO systems, including some store-brand versions. The concern is the meter’s E-5 error code, which can appear for two different reasons: a very high blood glucose reading above 600 mg/dL, or a test strip error.

That overlap matters because a person could mistake a dangerous high-glucose event for a strip problem and delay treatment. The reverse can also happen: someone might assume they have severe hyperglycemia when their blood sugar is actually normal or low and respond incorrectly.

The FDA says this issue is especially important for people on intensive insulin therapy, people taking sulfonylureas, and people who have frequent high or low blood sugar events. For those users, the agency says switching to an alternative glucose monitoring system is especially important.

The FDA also says not to stop checking blood sugar while waiting for another meter. Users should keep testing, consult a clinician or pharmacist about alternatives, and get medical help right away if an E-5 code appears along with symptoms of high or low blood sugar.

Practical warning signs of dangerous high or low blood sugar

Blood sugar problems can become urgent when symptoms are severe or changing quickly. Warning signs of very high blood sugar can include dehydration, confusion, and worsening illness. Warning signs of very low blood sugar can include shakiness, sweating, confusion, and passing out.

The CDC says blood sugar monitoring is important because food, activity, and medicines can all affect glucose levels throughout the day. Regular checks can help people spot patterns and give health care teams better information.

Seek urgent or emergency care if a person has severe symptoms such as confusion, loss of consciousness, trouble breathing, or signs of DKA, including persistent vomiting or severe illness with high blood sugar.

Simple next steps for patients, caregivers, and clinicians

Check whether an Omnipod pod lot or a TRUE METRIX meter is affected.
Follow replacement, correction, and labeling instructions from the manufacturer and FDA.
Keep monitoring blood glucose unless a clinician gives different instructions.
Ask a pharmacist, diabetes educator, or clinician about backup supplies or an alternate meter if needed.
For people using insulin, review what to do if a pod fails or a meter gives an unclear reading.

Bottom line

These updates are a reminder that device alarms and error codes are not always enough on their own. If a glucose device is affected, the safest move is to confirm the lot or model, follow official instructions, and keep blood sugar monitoring going while replacement options are arranged.

Sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.