At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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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A report of higher values was obtained while using the adc freestyle libre 2 sensor compared to a competitor¿s brand meter.On (b)(6) 2021, the customer experienced sweating, "distorted vision, lack of balance," and was unable to treat themselves and was provided orange juice by a non-hcp for treatment.A sensor scan of 3.0 mmol/l was compared to a blood glucose of 19 mmol/l on competitors brand meter, however, it is unknown if the values were taken at the time of the medical event.No further information was provided.There was no report of death or permanent injury.
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