The reported sensor ((b)(4)) was returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in sensor state 5 (indicating normal termination).Watermark was observed at the base of the tail, (indicating that the sensor was applied correctly).No failure modes were observed on the sensor plug assembly upon visual inspection.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.An extended investigation has also been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
|
A customer reported that a sensor error message was received on the adc device and as a result, the customer experienced symptoms described as ¿high pressure, low sugar, high heartbeats,¿ and a loss of consciousness.The customer had contact with a healthcare professional who check the customer¿s blood pressure and provided drinks, food, and salt for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
|