Parker Waichman LLP

OmniPod Insulin Device May Malfunction Insulet Warns

Insulet Corporation Issued Field Safety Notification to Omnipod Insulin Device. Insulet Corporation has issued a Field Safety Notification involving the OmniPod (Pod) Insulin Management System. The voluntary Nov. 2 alert, which was specific to 15 lots of the Pod, stated that the needle mechanism may fail to deploy or be slow to deploy. When this occurs, […]

OmniPod Insulin Device

Insulet Corporation Issued Field Safety Notification to Omnipod Insulin Device. Insulet Corporation has issued a Field Safety Notification involving the OmniPod (Pod) Insulin Management System.

The voluntary Nov. 2 alert, which was specific to 15 lots of the Pod, stated that the needle mechanism may fail to deploy or be slow to deploy.

When this occurs, insulin may not be properly delivered, leading to hyperglycemia in patients with diabetes. Diabetic ketoacidosis (DKA) can subsequently occur if elevated blood sugar levels are not treated.

There have been at least 66 Medical Device Reports related to this issue, the safety alert states. Three cases required medical intervention. The incidence rate in the affected lots is about 1 percent to 2 percent.

According to the alert, Insulet modified the manufacturing process and added more inspection measures after becoming aware of the problem. The OmniPod Personal Diabetes Manager (PDM) is unaffected by this recall.

Diabetes Patients Suffer Abnormally High Level of Sugar in The Blood

Patients with diabetes suffer from abnormally high levels of sugar in the blood. People with type 1 diabetes produce little or no insulin, a hormone that signals cells to take up glucose. In people with Type 2 diabetes, insulin is not being used properly.

In either case, cells are unable to take up glucose for energy and fat is burned instead. Ketone bodies, a product of fat breakdown, can change the pH of the blood and lead to DKA.

Symptoms of DKA may include dry or flushed skin, a fruity odor on the breath, difficulty breathing, nausea, vomiting, abdominal pain and dry or flushed skin. This condition can lead to a diabetic coma or death if untreated.

Need Legal Help Regarding Insulin Pump Device Lawsuit?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value
David Gillis Jr
3 years ago
5 Star Reviews 150
There was a point in my life I was going through some rough times I was hurt pretty bad and filled with a lot of pain I did not know if my accident case was was worth it until I called W( Parker Waichman ) they toke my case and made me feel at home also going over and Beyond for me all I can say is thank you very much & well done
W F
6 years ago
5 Star Reviews 150
Parker Waichman LLP helped my family with my father's 9/11 VCF Claim. My dad was in downtown Manhattan when 9/11 happened. Because of that he was diagnosed with COPD. Unfortunately, in early 2020 when COVID hit, he passed away. It was determined that his COPD from 9/11 was a contributing factor in his death. Working with Parker Waichman during such a difficult time was so helpful. Tina Morace was an absolute godsend in the process. Any questions I had, and there were many, were answered immediately. She always responded with a phone call and an email to follow so that I had everything in writing. I highly recommend their services to anyone who is in need.
Lisa Rooney
a month ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038