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.A clinical review has been conducted and this review has found no indication of any product clinical performance issues.A tripped trend review was conducted for the reported complaint and fs 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 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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A customer reported the adc freestyle libre 2 sensor detached after day 4 of wear due to bumping into something.On (b)(6) 2021, the customer went on a walk and experienced a hypoglycemic event, lost their balance, and was unable to treat themselves.The customer's husband provided the customer with food for treatment.There was no report of death or permanent injury associated with this event.
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