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 record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and 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 510k as customer is using fs libre 3 sensor with fs libre reader.Fs libre 3 sensor with reader is not approved for market in us, however libre 3 is same/similar to libre 2 which is currently on market in the us.All pertinent information available to abbott diabetes care has been submitted.
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A webform complaint was received in which an error message was reported on the adc device.Customer received a "scan again in 10 minutes" message and was unable to obtain readings.As a result, customer was about to lose consciousness and was unable to self-treat, requiring treatment of juice, sugar, and/or food provided by a medical professional (doctor, nurse, paramedic).There was no report of death or permanent impairment associated with this event.
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