An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced disorientation and was unable to self-treat, requiring treatment of a glucagon injection by a health-care professional.There was no report of death or permanent injury associated with this event.
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An alarm issue was reported with the adc application in use with a (samsung galaxy s22 plus+ 2.8.2.9318) phone with android 13 operating system.Customer experienced a signal loss and was unable to obtain readings.As a result, customer was not alerted of changes in glucose level and experienced disorientation and was unable to self-treat, requiring treatment of a glucagon injection by a health-care professional.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.
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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.
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