A Massive Recall Issued By FDA Over A Defective Medical Device Safety: Dexcom Diabetes Monitoring System
Despite the advances in the field of modern medicine, certain healthcare problems continue to represent major medical concerns for millions of patients everywhere. Among these major problems is diabetes. For those who might be unaware, diabetes has two separate types; however, both of these problems have to do with the failure of the body to produce and/or respond to insulin. This creates major problems for patients because they are unable to control their blood sugar. Failure to adequately control blood sugar can lead to problems with patients’ kidneys, nerves, eyes, and heart along with acute problems that can impact the proper neurological function of the body, a condition known as diabetic ketoacidosis. To try and control their blood sugar, patients must adequately monitor their blood sugar levels using a diabetes monitor and administer insulin in a proper manner. When problems with the diabetes monitor create medical device safety issues with defective medical devices, this can place the lives of patients everywhere at significant risk. Such was the problem with Dexcom defective medical devices, a company that manufactures a diabetes monitor, that created a medical safety issue for patients with diabetes everywhere due to their defective medical devices.
How does a Diabetes Monitor Work?
A diabetes monitor is supposed to track the patient’s blood sugar to ensure that the blood sugar doesn’t get too high or too low. If the blood sugar level drops too low, patients could start to feel tired and fatigued. To fix this, patients are supposed to take glucagon, a hormone that releases more glucose into the bloodstream. If the patient’s blood sugar levels get too high, they may start to feel jittery. To fix this, patients are supposed to take insulin, a hormone that will drop the body’s level of blood sugar. A diabetes monitor is supposed to track a patient’s blood sugar level by measuring the amount of glucose in the bloodstream. The classic diabetes monitor requires a finger stick blood glucose test. Patients would draw blood from the tip of their finger, place the blood on a strip, and the device would measure the amount of glucose in the blood. Because patients do not like having to prick themselves in the interest of medical safety, more advanced devices have been made that can measure blood sugar levels differently.
Who Oversees the Medical Safety of a Diabetes Monitor?
In the interest of the medical safety of a diabetes monitor, the government is responsible for overseeing the medical safety of each class of diabetes monitoring device. In the event of defective medical devices, liability issues could be at hand and recalls could be issued, possibility requiring a product liability attorney such as a defective product lawyer in McAllen TX. It is important for patients with diabetes and their loved ones to know what type of diabetes monitor they use and to keep up with any recalls for defective medical devices, such as the Dexcom defective devices because important medical safety issues could impact their quality of life.
What Problems with Medical Safety May Lead to Recalls?
With the specific nature of diabetes, there might be several reasons why the government could issue recalls for medical safety issues surrounding diabetes treatment devices. For example:
Improper Readings: Patients wear monitors to track their blood sugar levels. Sometimes, these levels can get too high or too low. Based on these readings, patients are supposed to administer hormones that will keep their blood sugar levels in check. If these readings are incorrect, patients may not know when to administer what hormone. The supervising organizations within the government offices could issue recalls for this.
Poor Hormone Administration: Many devices both read and administer hormones to help patients keep their glucose levels in check. It is possible that these devices may not properly administer the hormones. When this happens, the FDA ( Food and Drug Administration ) could issue recalls for those devices. For example, if patients are unable to administer insulin, it is possible that their glucose readings could shoot through the roof and lead to a condition called diabetic ketoacidosis. It is possible for patients to die from this condition. On the other hand, if patients are unable to administer glucagon, it is also possible for patient blood sugar levels to run low. In this situation, patients may wind up in a different type of coma as a result of their poor glucose levels.
Improper Alarms: Most devices have automated warnings that are supposed to create an audible sound when the patient’s blood sugar levels leave a predetermined range. When this happens, patients are alerted to the problem and are able to intervene quickly to correct whatever problem has developed. The safety organizations within the government are responsible for making sure that these sounds work properly and when they don’t, they issue recalls so that patients can swap out their defective products for products that work.
What Happened with the Dexcom Medical Devices?
Dexcom is a leading manufacturer of devices that are responsible for monitoring the glucose levels of patients with diabetes. These devices, which are monitored by various government oversight offices, include devices called the G4 Platinum and the G5 Mobile Continuous Monitoring System. Unfortunately, recalls have been issued for these two devices for a serious problem.
The devices are supposed to emit a loud, audible alarm when a patient’s blood sugar leaves a safe range. The government discovered that these Dexcom medical devices were not creating that audible alarm. This means that patients could have their glucose levels leave this safe range without them knowing. This could lead to diabetic ketoacidosis, a coma, or even death. For this reason, recalls have been issued for the Dexcom G4 and G5. Anyone who has been using these devices should return their device immediately and swap it out for one that works. Then, they could consider contacting an experienced liability attorney if you were harmed in any way.
Product Recalls Could be Issued Too Late
The government and medical community are responsible for monitoring these devices and for issuing recalls in the event that safety issues are found with devices. Sometimes, these defects are found too late and people could have already been injured or killed by a defect in the device. While Dexcom has been considered one of the gold standards in the world of diabetes treatment for years, these Dexcom medical devices have placed countless patients in harm’s way due to their lack of adequate alarm systems for patients with dangerous blood sugar levels.
Contact an Experienced Liability Attorney
If you or a loved one has been injured or harmed due to using a Dexcom medical device referenced above, it is important to contact an experienced product liability attorney at GOM Law. GOM Law’s defective product lawyer in Texas has the experience and expertise necessary to fight for justice on behalf of you and your loved ones. Do not allow defective medical device companies to produce medical equipment that places patients at risk. Contact an experienced product liability lawyer in McAllen TX today to learn how GOM Law can help you.