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

Model Number 71953-01

Device Problem Difficult or Delayed Activation (2577)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Numbness (2415); Cognitive Changes (2551)

Event Date 06/07/2023

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A button/power issue was reported with the abbott diabetes care (adc) device.The reader responded slowly when the touch screen was pressed.As a result, the customer experienced "dizziness", "facial paralysis", "language impairment", and was unable to self-treat, requiring third-party treatment of "fruit juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Event Description

A button/power issue was reported with the abbott diabetes care (adc) device.The reader responded slowly when the touch screen was pressed.As a result, the customer experienced "dizziness", "facial paralysis", "language impairment", and was unable to self-treat, requiring third-party treatment of "fruit juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.Reader turns on with start button.Sticky switch or slow response of button did not observed.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).Performed a continuity test on the returned usb cable using cable tester and no problem was found.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).Therefore issue is not confirmed.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.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.All pertinent information available to abbott diabetes care has been submitted.

• 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: 17224396
• MDR Text Key: 318081255
• Report Number: 2954323-2023-27867
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• 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