At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the 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.N/a was selected for pma/510(k) as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported a bent insertor needle with the adc device.The customer reported that due to improperly preparing sensor applicator, the sensor did not properly insert, and the customer therefore did not have working sensor to monitor glucose.The customer subsequently became hypoglycemic with cold sweating, and had contact with a healthcare provider.The customer was treated with a sugary-drink.There was no report of death or permanent injury associated with this event.
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