An alarm issue was reported with the adc device in use with iphone 13 mini, os version 16.6, app version 2.10.1.7653.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hypoglycemic symptoms and was unable to self-treat.The customer had contact with paramedics who administered unspecified treatment.There was no report of death or permanent impairment associated with this event.
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.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 and a valid lot or serial number has not been provided.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre sensor, no trends were identified that would indicate any product related issues.An extended investigation has been performed for the reported complaint and it has been determined that there were no issues with the librelink application that would have led to the complaint.The user reported signal loss.Successfully scanned and received glucose readings and alarm notifications using a similar configuration and unable to reproduce the complaint.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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