A complaint was received regarding a bent sensor tip when using the adc device.As a result, on (b)(4) 2022, the customer experienced symptoms of hypoglycemia described as sweating, depression, dizziness, and was unable to treat themselves hcp contact was made in the emergency room, and was provided oral glucose pills for treatment, no further information was provided.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 determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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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