The product was not returned for evaluation.We are unable to confirm the reported inaccurate high bg measurement or to determine if it could have contributed to the patient's hospitalization.No product lot number was reported therefore no lot release records were reviewed.The omnipod user guide warns "if you are experiencing symptoms that are not consistent with your blood glucose reading and you have followed all instructions described in this user guide, call your healthcare provider immediately," and advises "you should perform a control solution test when you suspect that your meter or test strips are not working properly, when you think your test results are not accurate, or if your test results are not consistent with how you feel.".
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