MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71892-01

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Diaphoresis (2452)

Event Date 07/16/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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.

Event Description

An alarm issue was reported with the adc device, with use of an iphone xs max with an ios operating system and version 16.5.1.It was reported that the high/low glucose alarm failed to sound and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced symptoms described as feeling unwell, sweaty, faint and hypoglycemia and was given oral glucose and food as treatment by a non-healthcare provider.No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

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 fa1029-2023.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.The.

Event Description

An alarm issue was reported with the adc application version 2.10.0.7647, in use with iphone xs max with ios operating system 16.5.1.Customer reported missing low glucose alarms and as a result, customer experienced " feeling unwell¿, faint, sweaty and was unable to self-treat, requiring third-party administration of oral glucose and food for treatment.Adc has identified that following the release of the freestyle librelink (fsll) application for ios, v2.10.0, on (b)(6)-2023 (11 a.M.) 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 issue does not affect users in the united states.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 fa1029-2023 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 17-jul-2023.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17402684
• MDR Text Key: 319828074
• Report Number: 2954323-2023-32313
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71892-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QR908720
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention