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

Model Number 71915-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 03/02/2024

Event Type  Injury  

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported that "no message appears." attempted to replicate customer complaint; however, per the abbott diabetes care compatibility guide for the freestyle librelink app, the reported configuration is not compatible with the freestyle librelink app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use the device manufacturing date does not apply.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 error message was reported with the abbott diabetes care (adc) in use with iphone 14 pro with ios operating system version 17.3.1., app version 2.10.2.7677.Customer reported that no message appeared on their application and was therefore unable to obtain readings.As a result, customer experienced low sugar levels and the customer was unable to self-treat, requiring non-hcp administration of juice.There was no report of death or permanent impairment 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: 18915392
• MDR Text Key: 337799573
• Report Number: 2954323-2024-09082
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71915-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention