Adc has identified a software defect for the freestyle libre 2 application with the android 13 os where the application may experience intermittent signal loss.As a result, the application user may not receive glucose results and/or glucose alarms and may not be alerted of low or high glucose conditions.Based on the investigation, this complaint is confirmed.This issue was addressed in the field by adc fa1010-2023.All pertinent information available to abbott diabetes care has been submitted.
|
An alarm issue was reported with the adc application in use with a samsung a33 phone android 13 operating system.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced convulsions and a loss of consciousness.Customer was provided glucagon by a third-party.There was no report of death or permanent injury associated with this event.The impacted product associated with this complaint is on market in the united states as well as the following countries ous: au, at, be, hr, cz, dk, fi, fr, de, gr, il, it, kw, lu, nl, nz, no, pl, pt, qa, sa, es, se, ch, tw, ae, gb, ca.Field action fa1010-2023 was issued to all impacted countries 08feb23.
|