The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported [er visit/hospitalization] and hypoglycemia. No lot release records were reviewed, as the product lot number was not provided. Omnipod insulin management system? User guide. Model: ust400. 17845-5a-aw rev b 09/17. Checking your blood glucose. Chapter 4 / page 36. Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia). Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia). If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider. Living with diabetes. Chapter 11 / page 119. Hypoglycemia can occur even when a pod is working properly. Never ignore the signs of low blood glucose, no matter how mild. If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness. If you suspect that your blood glucose level is low, check your blood glucose level to confirm.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient had been hospitalized with hypoglycemia. The patient's blood glucose levels were in the 40 mg/dl range while wearing the pod between 4 and 24 hours. The patient consumed some brown sugar, juice and glucose tablets. The patient had changed the personal diabetes manager settings while at work by decreasing insulin doses by 75 percent and back to 100 percent today. Once at the hospital the patient was treated with intravenous fluids, glucagon and ondansetron. The patient's blood glucose and insulin history are as follows: (b)(6).
Patient Sequence No: 1, Text Type: D, B5