Senseonics was made aware of a hypoglycemia event and user complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 at around 6 am.The measured blood glucose was 61 mg/dl and the sensor reading was 235 mg/dl.User did not receive any alerts.User was symptomatic, but did not want to provide information regarding self treatment, medical treatment or if hospitalization was required.
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This report is being submitted retrospectively as part of internal review.Based on the investigation analysis, there was a wound reported at the insertion site after the sensor was inserted on (b)(6) 2022.The wound at the insertion site was reported around the same time as the event was reported, on june 8.The wound may have contributed to temporary noise in the optical channel which in turn, may have caused temporary mismatch between the sensor readings and fingerstick measurements.Therefore the user experienced temporary differences between the sensor readings and fingerstick measurements.As the user was leaving for vacation, there was limited data following the event to analyze further.No further investigation was possible for this complaint.
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