Early Alert: Insulin Pump Issue from Insulet
Insulet has identified a defect in certain Omnipod Pods involving a tear in the tubing that can cause insulin to leak outside the device rather than being delivered to the patient.
This affects Insulet, users of the Omnipod system, and professional teams responsible for complaint handling and medical device reporting (MDR).
Failure to deliver insulin as programmed presents a significant clinical risk of hyperglycemia. From a regulatory standpoint, this indicates a mechanical failure in the fluid path, which may necessitate a formal recall, rigorous root cause analysis of the assembly process, and an evaluation of current quality control measures for tubing integrity.
QA teams should review manufacturing records for tubing integrity checks, while Regulatory and PV teams must prepare for potential increases in adverse event reporting related to under-delivery of medication. Verification of lot-specific distribution lists for potential field actions is advised.
Certain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body. <br>
Open in openFDA / FDA.gov