An adhesive issue was reported with the adc sensor.The sensor prematurely detached on day 4 of wear and the customer was unable to obtain readings.As a result, customer experienced symptoms of weakness, unable to stand, and unable to walk and was given a parmesan cheese, salami, and a gatorade drink as treatment by a non-healthcare provider.No further details were provided.There was no report of death or permanent injury associated with this event.
|
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit 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.
|