Insulet announced a voluntary Field Safety Notification for 15 lots of the OmniPod distributed in the U.S. and three lots distributed internationally since September 2015.
The Notification was issued due to increased reports of the OmniPod’s needle mechanism that failed to deploy or a delay in the deployment. Failure of the needle to deploy results in the insulin not being delivered. This interruption of insulin delivery may lead to hyperglycemia and diabetic ketoacidosis.
The affected lots include: #L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907 distributed in the U.S. and #L41908, L41910, and F41935 distributed internationally.
The Company has corrected the manufacturing process and implemented additional inspection steps since the issue was recognized. The OmniPod Personal Diabetes Manager (PDM) is not affected by this Safety Notification.
For more information call (855) 407-3729 or visit FDA.gov.