The customer reported that the blood glucose test would not start after applying sample, with the adc device.The customer developed symptoms of discomfort, trembling, paleness, blurred vision, and lost consciousness.The customer was treated with juice by a third-party.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 the provided serial number is not valid.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing 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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