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 record) 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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A caller reported on behalf of the customer a low readings issue with the freestyle libre sensor.The caller reported unspecified low readings with the freestyle libre sensor, which were lower than unspecified readings from a competitor meter.The customer experienced faintness and lost consciousness.He was instructed to treat with soda and candy by a doctor, through the phone.As the caller did not provide readings, it is unknown if the unspecified low readings were indicative of hypoglycemia, which would be consistent with treatment.There was no report of death or permanent injury associated with this event.
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