The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is (b)(4) compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneous reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6 per (b)(4) and eo residual levels in compliance with (b)(4).Each lot is confirmed to meet requirements for non-pyrogenicity per (b)(4) and sterility per (b)(4) prior to release.
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It was reported that the patient developed an infection at the pod¿s insertion site while wearing the device between 24 and 36 hours.Symptoms reported include skin irritation, discharge, swelling and a blood glucose level up to 300 mg/dl.Patient was prescribed clindamycin as treatment.
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