The product was not returned for evaluation.We are unable to confirm any product malfunction or other product condition to have contributed to the patient's hyperglycemia and er visit.No product lot number was reported therefore no lot release records were reviewed.Omnipod insulin management system ¿ user guide: model: cat45e/cat45f; 15546-aw rev d 06/2016.Checking your blood glucose 7 / page 98: warning: if you get results below 3.9 mmol/l or above 13.9 mmol/l, but do not have symptoms of hypoglycemia or hyperglycemia repeat the test.If you have symptoms or continue to get results that fall below 3.9 mmol/l or above 13.9 mmol/l, follow the treatment advice of your healthcare provider.
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It was reported that the patient¿s blood glucose, carbohydrate intake, and insulin history is as follows: (b)(6).She works at the hospital so she walked down to emergency room (er) to get some insulin as her insulin bottle is empty.At the er they asked her to deactivate the pod so they can give her a manual injection of 10 units of insulin.She was having chest pain, given citalopram for depression, given water and was told to lay down.She stayed at the hospital for 9 hours.The pod was worn between 24 and 36 hours on the leg.
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