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

Model Number 71994-01

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

Patient Problems Hypoglycemia (1912); Chills (2191); Dizziness (2194); Diaphoresis (2452)

Event Date 07/11/2022

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.Dhrs (device history record) for the libre sensor and libre sensor kits 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported obtaining a sensor error message from the adc device and was unable to obtain readings.The customer experienced chills, sweating, and dizziness, requiring treatment of juice and sugar from caregiver.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6)has been returned and investigated.A visual inspection has been performed and no physical damage is observed on sensor patch.Visual inspection was performed on the returned sensor plug and no failure modes were observed.Data was extracted from returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).De-cased the returned sensor and performed visual inspection of the printed circuit board assembly (pcba), no issues were observed.The returned battery has been measured and results were within specification.Therefore, this issue is confirmed to brown out reset.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported obtaining a sensor error message from the adc device and was unable to obtain readings.The customer experienced chills, sweating, and dizziness, requiring treatment of juice and sugar from caregiver.There was no report of death or permanent injury associated with this event.

• 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: 15060919
• MDR Text Key: 296207846
• Report Number: 2954323-2022-24756
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 71994-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2022
• 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