An alarm issue was reported with the abbott diabetes care (adc) device.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 a loss of consciousness, "knowledge loss", and was unable to self-treat, requiring third-party treatment of "water with sugar" by a non-healthcare 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 a71, version 2.8.2.9318) phone with 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 a loss of consciousness, "knowledge loss", and was unable to self-treat, requiring third-party treatment of "water with sugar" by a non-healthcare 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 08feb2023.
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