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

Model Number 71823-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Confusion/ Disorientation (2553)

Event Date 07/12/2023

Event Type  Injury  

Event Description

A customer reported an issue with the adc application, in use with samsung galaxy s21/os 12.The customer stated that the application was not working, but the customer was able to re-install the application with success.However, the customer was therefore unable to obtain readings for a duration of time and became tired and disoriented.The customer was treated with oral glucose by partner.Adc has identified that following the release of the freestyle librelink (fsll) application for android, v2.10.0, on 12-jul-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.

Manufacturer Narrative

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.

• 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: 17467032
• MDR Text Key: 320472380
• Report Number: 2954323-2023-33809
• 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
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71823-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• 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: QUALITY RECORD QR910952
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention