At this time, product has not yet been returned.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 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 caller called on behalf of the customer to inquire about the delivery of a replacement adc freestyle libre 2 sensor, sent due to initial report of a bent inserter needle.Tracking of the package noted the device was delivered; however, the customer was not notified by the delivery courier.As a result of not having replacement sensor, on (b)(6)2 022, the customer was brought to the hospital because of a "lung problem" and symptoms of dizziness and fatigue.The customer was provided unspecified third-party medical treatment.However, the caller could not provide further details regarding the medical event.There was no report of death or permanent injury associated with this event.
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