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

Model Number	71733-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported inquiry how to set-up account for app.Despite the software product type being linked to the complaint, the investigation found no connection between the customer's reported application and the customer's reported issue.The investigation did not identify the app as the cause of the issue as per customer's complaint was an inquiry on how to set up their account for the app.There is no malfunction with the customer's reported application.Therefore, the reported issue is not confirmed with respect to the customer's reported application.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An unspecified issue was reported with the abbott diabetes care (adc) application in use on an unknown phone with an unknown operating system and version.The customer inquired about how to install and connect to the librelink app and the steps required to do so.The customer was unable to access the freestyle librelink app due to an incorrect email and password combination.As a result, the customer was unable to monitor glucose readings.The customer experienced dizziness and self-treated with a glass of orange juice.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Common Device Name: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 24962123
• Report Number: 2954323-2026-40491
• Device Sequence Number: 11974346
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown