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Insulet Reports More Cases of OmniPod's Defective Needle Mechanism
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Through a voluntary field safety notification, Insulet Corporation is notifying consumers and health care professionals about a slight increase in reports in which the OmniPod's needle mechanism to deliver insulin fails to deploy or is delayed.
Through a voluntary field safety notification, Insulet Corporation is notifying consumers and health care professionals about a slight increase in reports in which the OmniPod’s needle mechanism to deliver insulin fails to deploy or is delayed.
The notification affects 15 lots of OmniPod distributed throughout the United States, and 3 lots distributed internationally.
Thus far, the issue has been reported in up to 2% of the affected lots.
When the needle of the OmniPod does not eject, it does not insert and deliver insulin. As a result, this may cause an elevated level of blood glucose, which can cause diabetic ketoacidosis. In the event that these symptoms occur, individuals are advised to seek medical attention immediately.
Those who have come across a defective OmniPod product are advised to contact Insulet Customer Care and report any adverse effects to the FDA’s MedWatch Adverse Reporting Program online.
After identifying the problem, the company has restructured its inspection steps and manufacturing process.
The affected US lot numbers are L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, and L41907.
