The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.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 device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.All pertinent information available to abbott diabetes care has been submitted.
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A "replace sensor" error message was reported with the adc device.The customer was therefore unable to obtain sensor readings.The customer experienced symptoms including shaking and palpitations.The customer was treated by a non-healthcare professional (non-hcp) who gave the customer jelly babies, a type of candy, and oral glucose.No additional treatment was provided by the non-hcp.There was no report of death or permanent injury associated with this event.
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Sensor (b)(6) was returned and investigated.The sensor plug was visibly not properly seated and no physical damage was observed on the sensor patch.Observed broken snaps and damaged sensor ear upon visual inspection of sensor plug assembly.This causes poor connection between the rubber contacts and printed circuit board (pcb) contacts, which may cause the sensor plug to be unable to form a proper seal.An extended investigation has also been performed on the sensor plug and observed that the snaps were broken off, causing improper seating of the plug in the mount.This resulting in a poor connection between the rubber contacts and printed circuit board (pcb) contacts, ultimately causing the sensor plug to be unable to form a proper seal, leading to possible liquid ingress onto the pcb.Therefore, this complaint is confirmed due broken side snap.All pertinent information available to abbott diabetes care has been submitted.
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A "replace sensor" error message was reported with the adc device.The customer was therefore unable to obtain sensor readings.The customer experienced symptoms including shaking and palpitations.The customer was treated by a non-healthcare professional (non-hcp) who gave the customer jelly babies, a type of candy, and oral glucose.No additional treatment was provided by the non-hcp.There was no report of death or permanent injury associated with this event.
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