A "scan again in 10 minutes" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced dizziness, shaking, tiredness, nausea, "eyes desorbitated," and a loss of consciousness; however, no treatment was reported after the customer regained consciousness.There was no report of death or permanent impairment associated with this event.
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The reported product is not expected to be returned as reporter indicated the device was discarded.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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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