MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Failure to Power Up (1476)

Patient Problems Fatigue (1849); Blurred Vision (2137); Loss of consciousness (2418)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/no power issue was reported with the adc device.A customer reported being unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer experienced feeling "tired, impaired speech, vision and body weakness," a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (grand-daughter) who sat with the customer and reported not providing long-acting insulin due to unspecified low glucose levels.There was no report of death or permanent injury associated with this event.

Event Description

A battery/no power issue was reported with the adc device.A customer reported being unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer experienced feeling "tired, impaired speech, vision and body weakness," a loss of consciousness and was unable to self-treat.Customer had contact with a non-healthcare professional third-party (grand-daughter) who sat with the customer and reported not providing long-acting insulin due to unspecified low glucose levels.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.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader and verification of correct cable and adapter were reviewed.The dhrs showed that the libre reader passed all tests prior to release and the correct cable and adapter were part of the kit pack.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section (h10 - additional mfg narrative ) was incorrectly documented in the previous report.Correction has been done.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING 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: 18288572
• MDR Text Key: 329992571
• Report Number: 2954323-2023-53139
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• 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: 03/06/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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
• Patient Sex: Female