The product was not returned for evaluation.We are unable to assess if any product condition could have contributed to the patient's infection.No lot release and sterilization records were reviewed because no product lot number was reported.Omnipod insulin management system ¿ user guide: model: ent450, 17845-5c-aw rev a 10/17; changing your pod 3 / page 24.Warning: to minimize the possibility of site infection, do not apply a pod without first using aseptic technique.This means to wash your hands, clean the insulin vial with an alcohol prep swab, clean the infusion site with soap and water and keep sterile materials away from any possible germs.Changing your pod 3 / page 34.Warning: if an infusion site shows signs of infection; immediately remove the pod and apply a new one at a different site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes 11 / page 117.At least once a day, use the pod¿s viewing window to inspect the infusion site.Check the site for signs of infection, such as pain, swelling, redness, discharge or heat.
|
The patient reported that after wearing the pod between 36 and 48 hours on the back, he noticed his site was painful, infected, and a cyst noted at the insertion site.He went to the hospital where they had to surgically remove the cyst.They also prescribed antibiotics for the site infection.The patient¿s blood glucose reached greater than 300 mg/dl.
|