An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced symptoms of hyperglycemia, sleepy, blurred vision and was unable to self-treat.Customer had contact with a healthcare professional who provided an unspecified (dose/type) insulin injection as treatment and was hospitalized until (b)(6) 2023.There was no report of death or permanent impairment 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 there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle libre sensor kit was reviewed and the dhrs showed the freestyle 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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