This complaint was investigated.Adc has identified a software defect for the freestyle librelink application for android version 2.10.0.During periods of signal loss, old glucose data would appear as current data, thus allowing for potential of erroneous glucose results.In addition, the signal loss alarm would not function properly, even though it would appear as enabled.This issue was addressed in the field by adc fa1032-2023 and was resolved on 31-jul-2023 with the release of an updated application version 2.10.1.Based on the investigation, the complaint is confirmed and no further investigation activities for this individual complaint are required.The device model number populated in section d4 is for the freestyle librelink android application, on market in the uk/ireland.This is same/similar to us freestyle librelink/freestyle libre 2 ios application part number 71733-01/71926-01.All pertinent information available to abbott diabetes care has been submitted.
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A caller reported a signal loss issue when using the adc application, with use with lg g4 phone/os 8.0.The customer reported that due to this issue, they experienced fatigue and subsequent loss of consciousness.The customer required treated of glucagon injection and glucose gel by caregiver.Adc has identified that following the release of the freestyle librelink (fsll) application for android, v2.10.0, on (b)(6) 2023 in the united kingdom and ireland, some users have experienced a situation in which the application upgrade was unsuccessful and during periods of signal loss, old glucose data would appear as current data, thus allowing for the potential of erroneous glucose results.In addition, the signal loss alarm would not function properly, even though it would appear as enabled.This issue was addressed in the field by adc fa1032-2023.This issue does not affect users in the united states.There was no report of death or permanent injury associated with this event.
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