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OmniPod Urgent Safety Notification


 

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This Field Safety Notification affects the Pods. The following OmniPod lots had an increased incidence in which the needle mechanism failed to deploy or delayed in deployment. U.S. Lot Numbers:

  • L41880
  • L41898
  • L41903
  • L41881
  • L41899
  • L41904
  • L41892
  • L41900
  • L41905
  • L41895
  • L41901
  • L41906
  • L41897
  • L41902
  • L41907

The lot number is located on the Pod tray lid label, the side of the Pod and on the end of the box of Pods.

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Insulet Recalls approximately 400,000 OmniPods


Insulet Corporation launched a voluntary recall of more than 40,000 boxes of the OmniPod Insulin Management System. Each box contains 10 OmniPods meaning there are approximately 400,000 pods that are recalled. The reason for the recall is the devices could have a higher rate of failure than the company’s current manufacturing standards.

According to Insulet, the cannula (the needle for injection) may either completely retract or fail to fully deploy, meaning the patient does not receive the expected insulin dose, or the pod triggers an audible alarm indicating that it will no longer deliver insulin and should be replaced. This problem is reported in over 200 Adverse Event Reports on the Food and Drug Administration (FDA) website, many stating this issue required medical intervention. OmniPods from the affected lots were distributed from December 2013 to March 2015.

Distribution

FDA MedWatch (08/28/15)

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460197.htm
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What is a OmniPod?


The OmniPod Insulin Management System is marketed as a device that allows diabetics to conveniently and effortlessly deliver insulin. The insulin pump is self-contained and attaches to the patient’s skin. The device primes automatically, and inserts insulin through a small automated needle. The dosage and frequency of insulin delivery is monitored through a portable electronic device. The pump is primarily marketed towards children and other young, active people with diabetes.

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