A customer reported that the adc device applicator needle became bent and therefore customer could not apply sensor.The customer subsequently experienced fatigue, nausea, and loss of consciousness.The customer had contact with a healthcare professional but did not provide treatment information.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.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.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and 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.
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