Missed Smartphone Alerts Could Lead to Life-Threatening Consequences for Patients
The U.S. Food and Drug Administration (FDA) has issued a warning to patients and caregivers using diabetes-related medical devices, cautioning that users may not receive critical safety alerts from their smartphones. The issue affects continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes management devices that rely on mobile medical apps for safety notifications. According to the FDA, failure to receive these alerts could result in severe health complications, including extreme blood sugar fluctuations, diabetic ketoacidosis, and even death.
This warning highlights the risks associated with smartphone settings and software updates that may interfere with the proper functioning of medical device alerts. The FDA has identified several potential causes of alert failures, including notification permissions being disabled, “Do Not Disturb” or “Focus Mode” settings preventing alerts from sounding, and mobile apps going into “deep sleep” mode when unused for an extended period. Additional concerns arise when connecting wireless headphones or car audio systems, which can automatically change notification volume or block alert sounds altogether.
The warning also extends to smartphone operating system (OS) updates, which may not be immediately compatible with diabetes-related medical apps. If a patient updates their phone’s OS before ensuring compatibility with their diabetes device app, alerts may fail to function as intended. The FDA advises patients to disable automatic OS updates and verify compatibility with medical device manufacturers before updating their smartphones.
Patients and caregivers are urged to regularly check their smartphone settings to confirm that medical alerts are configured correctly and that notifications remain active. The FDA recommends performing these checks at least once a month and anytime a device’s software is updated or a new hardware accessory is connected. If a user experiences issues with receiving alerts, they should contact the medical device manufacturer’s technical support for assistance.
The FDA has assured the public that it is working closely with diabetes device manufacturers to evaluate smartphone alert configurations, ensure ongoing testing, and communicate recommended settings to users. The agency will continue monitoring the situation and provide updates if further safety concerns emerge.
The Health Risks of Missed Alerts for Diabetes Patients
Patients who rely on CGMs and insulin pumps depend on timely alerts to manage their blood sugar levels and prevent dangerous fluctuations. When a smartphone fails to deliver critical notifications, the consequences can be severe. Missing an alert for low blood sugar, known as hypoglycemia, can cause confusion, dizziness, seizures, or loss of consciousness. If left untreated, severe hypoglycemia can be fatal.
On the other hand, failing to receive an alert about high blood sugar, or hyperglycemia, can lead to diabetic ketoacidosis (DKA), a serious condition where the body breaks down fat for energy, producing high levels of acids called ketones. DKA can cause vomiting, dehydration, difficulty breathing, and, if untreated, coma or death. Patients rely on real-time alerts to take corrective action, whether that means consuming sugar to raise blood glucose or administering insulin to lower it.
Missed alerts also put children and elderly patients at increased risk. Many caregivers use smartphone-connected devices to monitor the health of loved ones remotely. If a caregiver does not receive an alert due to a phone setting or software issue, they may be unaware that the patient requires immediate medical attention. This delay can be especially dangerous for individuals who are unable to recognize or communicate their symptoms.
Legal Rights and Filing a Lawsuit Over Diabetes Device Alert Failures
Patients harmed due to missed diabetes device alerts may have the right to file a product liability lawsuit against the device manufacturer or app developer. When a medical device fails due to a design flaw, software issue, or inadequate warnings about risks, the manufacturer may be held legally responsible for any resulting injuries or deaths.
A lawsuit could be based on claims of product defects, failure to warn, or negligence in ensuring that the medical app functions reliably on commonly used smartphones. If a patient suffers from severe complications due to a missed alert, legal action may be an option to seek financial recovery for medical bills, lost wages, and pain and suffering.
The Process of Filing a Lawsuit Against a Medical Device Manufacturer
Filing a lawsuit for injuries caused by a malfunctioning diabetes device involves several key steps. The first step is gathering evidence, including medical records, device logs, and any documentation showing that the app failed to deliver alerts as expected. A legal team will review this evidence and determine whether there is a strong case against the manufacturer.
Once the claim is filed, both sides will enter the discovery phase, where attorneys exchange information and investigate the cause of the failure. This stage may include testimony from medical experts, product engineers, and patients who experienced similar alert failures. If the manufacturer is found liable for the defect, they may offer a settlement to compensate the victim. If a fair settlement is not reached, the case may proceed to trial.
Why Legal Representation is Crucial for Patients Seeking Compensation
Diabetes device manufacturers have vast legal resources to defend against product liability claims. Patients attempting to handle a lawsuit on their own may struggle to prove the manufacturer’s responsibility or calculate the full extent of their damages. Legal representation ensures that the case is handled professionally, with medical experts and technical specialists providing evidence of the device’s failure.
An attorney can help victims understand their rights, gather critical evidence, and negotiate for a fair settlement. If the case goes to trial, legal counsel will present the strongest possible argument to hold the manufacturer accountable. Without professional legal guidance, patients risk missing out on the compensation they deserve or facing delays in the legal process.
Compensation Available in a Product Liability Lawsuit
Victims who suffer harm due to a malfunctioning diabetes device app may be entitled to several types of compensation. This can include:
- Medical Expenses: Coverage for hospital visits, medications, and ongoing treatment for diabetes-related complications.
- Lost Wages: Compensation for time away from work due to illness or medical appointments.
- Pain and Suffering: Damages for physical pain, emotional distress, and reduced quality of life.
- Wrongful Death Compensation: Families who lose a loved one due to a missed alert may be eligible for compensation to cover funeral expenses and loss of financial support.
If you or a loved one suffered harm due to missed diabetes device alerts, you may have grounds for legal action. The national product injury law firm Parker Waichman LLP is dedicated to helping victims hold medical device manufacturers accountable.
.svg){kind=small}
.avif)
.avif)
