This complaint was investigated.Adc has identified a software defect for the freestyle librelink application for ios, version 2.10.0, in which the application upgrade was unsuccessful.This resulted in a period where users may not have received glucose results or may not have been alerted to low or high glucose alarms.Based on the investigation, the complaint is confirmed and no further investigation activities for this individual complaint are required.This issue was addressed in the field by adc (b)(4).The device model number populated in section d4 is for the freestyle librelink ios application, on market in the uk.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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An unexpected application error was reported with the adc application version unknown, in use with iphone 10 with ios operating system version unknown.As a result, the customer experienced weakness, shakiness, and a loss of consciousness; however, after regaining consciousness the customer indicated no treatment was administered.No further information was provided.Adc has identified that following the release of the freestyle librelink (fsll) application for ios, v2.10.0, on (b)(6) 2023 (11am) in the united kingdom (uk), some users have experienced a situation where the application upgrade is unsuccessful, and as a result, they receive a white screen in the application user interface (ui).This will result in a period where glucose readings and alarms will not be received, and historical glucose readings will not be accessible, as the previous fsll application, v2.8.1, was no longer available to users on the apple app store.This issue was addressed in the field by adc (b)(4) and was resolved in the field by the release of updated fsll ios application, made available in the apple app store in the uk on (b)(6) 2023.There was no report of death or permanent injury associated with this event.
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