An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced symptoms described as "dizziness, nausea, lightheadedness, extreme tremors, very severe headaches," a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional (hcp) who provided glucose gel as treatment for the diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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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 sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.As it is unknown if the user was using android or ios with the fs libre 3 sensor, g4 - pma/510(k) # has been populated for ios.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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