A customer reported being unable to test using the adc device due to a fast-draining battery and reported "does not always turn on".As a result, the customer experienced symptoms of "feeling weak, could not take glycemia," and was unable to self-treat.Customer had contact with a non-healthcare professional third-party who provided "rescue" as treatment.There was no report of death or permanent injury 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 it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and freestyle libre reader and no trends were identified that would indicate any 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.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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