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

Model Number 71857-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Fatigue (1849); Hypoglycemia (1912)

Event Date 01/23/2023

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 mfg date is unknown.The date entered 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 alarming issue was reported while using freestyle librelink, the abbott diabetes care (adc) device.A customer reported that the sensor¿s alarm failed to trigger when their glucose was low and as a result, the customer became hypoglycemic with symptoms described as ¿hunger¿, and fatigue.The customer was unable to self-treat, requiring treatment of juice and glucose-infused snacks by a non-healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report and a valid serial number was not provided.Extended investigation has been performed for the reported complaint and there was no indication that the librelink application did not meet specification.The user reported missing low glucose alarm with the freestyle librelink application.Attempted to recreate the user complaint using a similar configuration was able to successfully receive glucose alarm notifications and was not able to reproduce the complaint.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarming issue was reported while using freestyle librelink, the abbott diabetes care (adc) device in use with samsung galaxy s10/ os12.A customer reported that the sensor¿s alarm failed to trigger when their glucose was low and as a result, the customer became hypoglycemic with symptoms described as ¿hunger¿, and fatigue.The customer was unable to self-treat, requiring treatment of juice and glucose-infused snacks by a non-healthcare professional.No further information was provided.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: 16410295
• MDR Text Key: 309895033
• Report Number: 2954323-2023-07490
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71857-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention