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 review) for the libre sensor and libre sensor kit 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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Customer stated that after inserting the adc sensor, the needle was sticking out from the sensor and as a result, customer was unable to obtain readings and lost consciousness.Customer was able to self-treat and would attempt to see a healthcare professional, however, no hcp treatment was reported.There was no report of death or permanent impairment associated with this event.
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