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.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported alarms not available.The reported issue was investigated and attempted to be replicated using similar configurations of an a5x phone and the freestyle librelink special edition app version 21.0.0.6714.The reported issue was unable to be replicated and the system functioned as intended, assuming the customer had the appropriate phone settings enabled, including notification, sound, battery, and bluetooth.An "alarms unavailable" message may be displayed if the appropriate phone settings are not enabled.There were no issues identified with the freestyle librelink special edition app during replication that would have led to the reported issue as the case did not state that the appropriate phone settings were disabled.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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An alarm issue was reported with the abbott diabetes care (adc) device.The customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced symptoms described as "dizzy, lost balance, and a seizure.The customer was unable to self-treat, requiring treatment of dextrose by a healthcare professional.It was further reported at the time of incident, customer's sugar was "19" and then "4.5" but it unknown when this result was taken in relation to the treatment or what device it was obtained from as no further information was provided.There was no report of death or permanent impairment associated with this event.
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