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

Model Number 71953-01

Device Problem Battery Problem (2885)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/03/2022

Event Type  Injury  

Event Description

A customer reported via social media post that they were unable to charge the adc device.The customer indicated that due to this issue, they were unable to monitor glucose and became "unresponsive" due to low blood sugar, causing wife to call for an ambulance.No additional details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing 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.

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 was reviewed and the dhrs showed the 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 customer reported via social media post that they were unable to charge the adc device.The customer indicated that due to this issue, they were unable to monitor glucose and became "unresponsive" due to low blood sugar, causing wife to call for an ambulance.No additional details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The returned reader was investigated.Reader powered on with button depression.No new issues were observed.Observed reader to be charging when plugged into outlet.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported via social media post that they were unable to charge the adc device.The customer indicated that due to this issue, they were unable to monitor glucose and became "unresponsive" due to low blood sugar, causing wife to call for an ambulance.No additional details were provided.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported via social media post that they were unable to charge the adc device.The customer indicated that due to this issue, they were unable to monitor glucose and became "unresponsive" due to low blood sugar, causing wife to call for an ambulance.No additional details were provided.There was no report of death or permanent injury associated with this event.

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 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 reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader powered on with button depression.Observed reader to be charging when plugged into outlet.The user complaint could not be reproduced.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the follow #1 & #2 report.Correction has been made.

• Brand Name: LIBRE 2 READER FREESTYLE
• 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: 16074957
• MDR Text Key: 306406748
• Report Number: 2954323-2022-47557
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599804008
• UDI-Public: 00357599804008
• 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,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2021
• 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