An alarm issue was reported with the adc device.The low glucose alarm did not sound and customer was unaware of changes in glucose levels.As a result, customer reported "feeling hypoglycemic" and was unable to self-treat, requiring treatment of "sweets, biscuits, and tea" from a third-party.There was no report of death or permanent injury associated with this event.
|
An alarm issue was reported with the adc application in use with a samsung galaxy (b)(6)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 reported "feeling hypoglycemic" and was unable to self-treat, requiring treatment of "sweets, biscuits, and tea" from 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.
|