At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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The customer's husband reported a low reading issue with the adc freestyle libre 2 sensor.The husband reported that on the morning of (b)(6) 2020, the customer was disoriented, weak, and not fully conscious, and the husband obtained a scan reading of 10.6 mmol/l.The husband reported the customer's scan values to be 7-8 mmol/l throughout the day.In the evening, the customer was still not well and emergency health professionals were called to the customer's home.A blood glucose value of 19 mmol/l was obtained by the healthcare professionals, as compared to a sensor scan of 7 mmol/l.The customer was diagnosed with hyperglycemia and treated with insulin (dose/type unknown) by a third-party.There was no report of death or permanent injury associated with this event.
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