A low readings issue was reported with the adc device.A customer reported receiving low sensor readings compared to a healthcare professional (hcp) meter and as a result, customer experienced symptoms described as "vomiting, color change," and unable to self-treat.Customer had contact with an hcp who obtained a blood glucose result of 600 mg/dl compared to a sensor scan of ¿hi¿ (greater than 500 mg/dl) and provided an unspecified (dose/type) insulin as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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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.At this time product has not yet been returned for this complaint.A valid serial number was not provided.Clinical and stability were reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for 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 libre sensors, no trends were identified that would indicate any product related issues.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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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