A recall on insulin pump pods has been designated by the U.S. Food and Drug Administration (FDA) as a Class I recall, the agency's most serious type after 29 serious injuries were reported.
To date, there have been no deaths associated with the defective devices, manufactured by Massachusetts-based Insulet. However, certain lots of the Omnipod 5—used in an automated insulin delivery system for those with Type 1 diabetes—will need to be removed from where they are used or sold in order to prevent any potential fatalities.
The insulin pump system, known for its invisible tubing unlike other wearable models on the market, uses a proprietary set of patches to administer insulin into the body as glucose levels change in diabetic patients throughout the day.
Omnipod 5, when functioning as intended, should correct insulin levels in the body every five minutes.
The issue with the recalled lot, according to Insulet which first announced the recall in a letter to known customers on March 12, stems from a manufacturing defect on the pods. Internal tubes within the devices that insulin flows through may contain small tears, leading to leaks that could cause an underdelivery of insulin.
As a result, patients may not receive the proper dose from the pump, leaving them with higher-than-expected blood sugar levels. This could lead to diabetic ketoacidosis, a potentially life-threatening condition that could cause patients to become delirious or unresponsive, putting others at risk if the patient is driving a car or operating heavy machinery.
Diabetic ketoacidosis requires immediate medical attention to mitigate.
Worse yet, the tears in the pods could cause the insulin pumps to enter a state of Automated Delivery Restriction, due to it not registering an underdose of insulin being delivered. This could happen without warning or alert, leaving the patient unaware that they received a lower-than-necessary dose of treatment.
While there is an alarm that is supposed to trigger if insulin enters the pod, that is reportedly not always happening.
The only solution, according to Insulet and the FDA, is to find a replacement for the defective pods. That starts with identifying those deemed defective.
What is being recalled?
The above image shows the packing for the Omnipod 5. The following is how the units with the potential leaky tears can be spotted.
- Unique Device Identifier: 10385083000527
- Click here for a full List of Affected Product
Next steps
Defective pods must not be used. If a patient does not have replacements, they should seek alternatives from their medical provider.
All products must be checked to see if they match the recall information above, including those currently being worn by patients.
In a letter sent to known Omnipod 5 customers in March, Insulet provided a form to return unused products and request replacements. Since that time, the list of defective units has been expanded to include those with expiration dates that have passed, so it’s important to check the above link for the full list of affected products.
Those with questions are advised to contact Insulet at 1-800-641-2049. The company said its service line is available 24 hours a day, seven days a week.
For more details, read the full FDA recall notice by clicking here.
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