The FDA has flagged two Class I medical device recalls and corrections, affecting blood glucose monitors and insulin pumps.
Here are two recalls to know:
- Blood glucose monitors (Trividia Health): On April 28, Trividia issued a correction for True Metrix blood glucose monitoring systems due to an issue with the E-5 error code, which may indicate either very high blood glucose levels or a test strip error. Misinterpretation could delay treatment or lead to improper treatment, with risks including loss of consciousness or death. The FDA reported 114 serious injuries and one death.
- Insulin pumps (Insulet): On April 30, Insulet recalled certain Omnipod 5 Pods due to a defect that may cause insulin under-delivery. The issue could lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis. The FDA reported 29 serious injuries and no deaths.
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