May 31, 2017 · FLEMING | NOLEN | JEZ, L.L.P.
Our attorneys at Fleming, Nolen & Jez are currently investigating the OmniPod Insulin Management System for its serious adverse events, including death.
Class 2 Device. There are two pieces to the system: The Personal Diabetes Manager “PDM” and the pod which attaches to the patient.
The PDM is the second part of the system. This smartphone-looking device is what the diabetes patient uses to control the system. The PDM has a freestyle blood glucose meter built in.
Diabetes is a metabolic disease that affects many different parts of the body. Depending on the type of diabetes the body cannot produce insulin itself (Type 1) or its unable to use the insulin it produces properly (Type 2).
Insulin is a hormone, a chemical messenger that is transported in the blood and regulates important body functions. Without insulin, your body cannot get the energy it needs from the food you have eaten. Without insulin, our bodies cannot use the sugar in our blood so the sugar builds up there. Very high blood sugar concentrations can cause a number of symptoms.
The pod is a patch-like device that is made to adhere to the skin of the patient. The cannula/needle pierces the skin and delivers the insulin. The device can hold up to 200 units of insulin.
After 72 hours (3 days) the pod is disposed of by the patient and a new one is used.
The pod should deliver insulin for 3 days but in most cases it doesn’t last more than 2 days.
Approximately 1.25 million American children and adults have type 1 diabetes.
Medicare views the OmniPod as being two separate items; the tubeless insulin pods and the PDM. Although insulin is considered medically necessary, the tubeless pods that deliver the insulin are disposable, which disqualifies it as being medically necessary or as durable medical equipment.
However, some insurance companies consider these types of pumps to be investigational and therefore, not medically necessary.
This chart displays the continued increase in adverse events that users of the OmniPod are encountering. OminPod is listed in blue and it’s competitor Medtronic Minimed is in green.
These complications can occur if you don’t get your dosage.
In March, the FDA found Omnipod failed to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90 (a). Specifically, they had released OmniPods that failed release testing and were released through a nonconformity review despite all lots falling below the firm’s quality assurance final acceptance criteria.
If the pod leaks, there is no way to access the remaining insulin and another pod will need to be used. If the alarm sounds, it may not dispense the insulin and you will need to use another pod. At times, there is no communication between the pod and PDM monitor. There are instances of patients/parents calling 911 when they have their glucose tested in the ER the number is different from the one on the device. There is also a report of an OmniPod exploding.
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