The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization for diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.The omnipod¿s user guide warns to "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 250 mg/dl, follow the treatment advice of your healthcare provider," and "if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death." it advises ¿the easiest and most reliable way to avoid dka is by checking your blood glucose at least 4¿6 times a day.Routine checks allow you to identify and treat high blood glucose before dka develops.".
|
The patient reported having a blood glucose level that reached 437 mg/dl after wearing the pod on their arm between 4 and 24 hours.After four hours of high blood glucose, the pod was changed and ketones were checked.In the morning, there were no ketones, and then later, there were large ketones.The patient was admitted to the hospital and diagnosed with diabetic ketoacidosis.He was placed on an insulin drip which brought his blood glucose down to 105mg/dl.New pod was placed on and his blood glucose level increased to 380 mg/dl.The doctor and mother both feel the pdm is having issues communicating with the pod, since the pods didn't give errors and the pods appeared normal and the insulin was fine.Pdm was requested to be replaced.History: icr: (breakfast)1: 14; (lunch) 1:88; (dinner) 1:14; 10:44pm deactivated ( in hospital); 932 p suspend begin (in hospital); 932pm basal.6; 9:32 resume (in hospital); 7:37 suspend done (in hospital); 7:37 suspend begin (in hospital); 7:36 basal.60 units; 7:36 resume (in hospital); 5:36 suspend (in hospital); 3:00 bg 431; 2:09 bolus 2.6; 2:08 bg 498; 12:36 bolus 4.8 carb 15; 1235 bg 394; 9:00 basal.6 856 bolus 2.15; 8:56 bg 295; 6:02 bolus 2.05 bg 406.
|