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

Model Number 71953-01

Device Problem Premature Discharge of Battery (1057)

Patient Problems Hyperglycemia (1905); Dizziness (2194); Numbness (2415); Cognitive Changes (2551)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.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 device history review (dhrs) for the libre 2 reader were reviewed and the dhrs showed the libre 2 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/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced "dizziness", "muscle numbness", "difficulty thinking", and was unable to self-treat, requiring contact with emergency services who transported customer to the hospital.At the hospital, a healthcare professional (hcp) provided third-party treatment of "insulin injection" (type/dose unspecified) for a diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.

Event Description

A battery/power issue was reported with the abbott diabetes care (adc) device.Customer reported being unable to test due to a fast draining battery.As a result, customer experienced "dizziness", "muscle numbness", "difficulty thinking", and was unable to self-treat, requiring contact with emergency services who transported customer to the hospital.At the hospital, a healthcare professional (hcp) provided third-party treatment of "insulin injection" (type/dose unspecified) for a diagnosis of hyperglycemia.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.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.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issue were observed.Reader was sufficiently charged.Visually inspected the returned usb charger and usb cable and no damage was observed.Performed load test on the usb charger and results were within specification range (4.75v-5.25v).Visual inspection has been performed on the power adapter and no issues were observed.The power adapter voltage was measured to be within specification range (4.75v-5.25v).The returned reader was de-cased and visual inspection was performed on the returned reader and no issues were observed.The stm processor was present.An extended visual inspection has been performed on the retuned reader and reader's pcba (printed circuit board assembly); no issues were observed.Adapter and cable test was performed and all results were within the specifications.No issue were observed with the returned supplied charging cable.Off current test was performed and results were within the specifications.Therefore, issue is not confirmed due to fast draining battery not observed.All pertinent information available to abbott diabetes care has been submitted.This also serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the initial report.Correction has been made.

• 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: 18054369
• MDR Text Key: 327128329
• Report Number: 2954323-2023-48291
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/09/2024

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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