A webform complaint was received in which 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 dizziness, migraines and was unable to self-treat, requiring treatment of juice by third-party.There was no report of death or permanent injury associated with this event.
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A webform complaint was received in which an alarm issue was reported with the adc application in use with a samsung galaxy a32 5g phone with android operating system.Customer experienced a signal loss and was unable to receive glucose alarms.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, customer was not alerted of changes in glucose level and experienced dizziness, migraines and was unable to self-treat, requiring treatment of juice by 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.
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Adc has identified a software defect for the freestyle libre 2 application samsung galaxy a32 5g phone 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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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