MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Tachycardia (2095)

Event Date 10/28/2022

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 review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.It is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported via webform they received a "sensor error" message from the adc device.The customer was able to be contacted and indicated experiencing symptoms of tachycardia and "soft knees." the customer received treatment of grape sugar provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 (udi) has been updated.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch or adhesive.Visual inspection was performed on the returned puck and no issues or abnormalities were observed.Data was downloaded successfully, brownout error was observed.This error indicates that the returned puck terminated due to a brownout event.The returned puck was de-cased and observed the puck had experienced liquid ingress due to having a leak path.Therefore, this issue is confirmed to brownout reset due to liquid ingress.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported via webform they received a "sensor error" message from the adc device.The customer was able to be contacted and indicated experiencing symptoms of tachycardia and "soft knees." the customer received treatment of grape sugar provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 15859604
• MDR Text Key: 304276089
• Report Number: 2954323-2022-43051
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2022
• 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