An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported the adc freestyle libre 2 sensor detached after 4 days of wear.On (b)(6) 2021, as a result, the customer experienced chills, sweats, and was unable to treat themselves.The customer called emergency services and was provided an unspecified infusion and oral glucose for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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