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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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A high readings issue with the adc device was reported.Customer received a high sensor scan result of 170 mg/dl and took a "correction bolus" and went to rest.When the customer had awoken, they experienced feeling hazy, dizzy, swaying from side to side, and a loss of consciousness.Customer's mother gave them a cup and a half of grape juice, but after that, the customer started to have convulsions, shaking, "eyes were rolling".The mother then gave the customer more sugar.An ambulance was called, and customer was treated with glucose gel by the paramedic and taken to the emergency room.No glucose level measurements were performed with the sensor or with the blood glucose meter.When the customer arrived at the emergency room, they already felt better and refused further tests or treatment.No further treatment was reported.There was no report of death or permanent injury associated with this event.
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