The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported er visit and diabetic ketoacidosis with hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. Omnipod dash insulin management system? User guide. Model: 18320. 18296-eng-aw rev b 06/18. Changing your pod. Chapter 3 / page 37. Warnings: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin. Living with diabetes. Chapter 13 / page 171. Infusion site checks at least once a day, use the pod's viewing window to inspect the infusion site. Check the site for: leakage or scent of insulin, which may indicate the cannula has dislodged. Signs of infection, such as pain, swelling, redness, discharge, or heat.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient's blood glucose (bg) values reached 555 mg/dl. The patient went to the emergency room, where they were diagnosed with diabetic ketoacidosis (dka). The patient was given intravenous (iv) fluids and blood work was given, as treatment. The patient reported that the adhesive was lifted where the cannula is located and the cannula was dislodged, as a result. The patient changed out the pod for a new pod.
Patient Sequence No: 1, Text Type: D, B5