The product has been requested back for an investigation.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.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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An unspecified error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced heavy sweating, tremors, blurred vision, ¿heart beats very hard¿, and seizure.Customer was able to self-treat with 4 tablets of the dextrose, honey, and orange juice.No further treatment was required.There was no report of death or permanent impairment associated with this event.
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