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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Headache (1880); Hypoglycemia (1912); Tachycardia (2095)

Event Date 12/04/2022

Event Type  Injury  

Manufacturer Narrative

At this time the product has not been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.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

An alarm issue was reported with the adc device.The low glucose alarm did not sound, and customer was unaware of changes in glucose levels.As a result, customer experienced hypoglycemia, tachycardia, headache, and pallor and was unable to self-treat, requiring third-party administration of oral sugar.There was no report of death or permanent injury associated with this event.

Event Description

An alarm issue was reported with the adc device.The low glucose alarm did not sound, and customer was unaware of changes in glucose levels.As a result, customer experienced hypoglycemia, tachycardia, headache, and pallor and was unable to self-treat, requiring third-party administration of oral sugar.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), and signal loss message was observed.Since the sensor and known good reader communicated successfully, and a signal loss message was observed after simulating a signal loss, the returned sensor was found to be functioning properly.Sensor was scanned with reader to re-establish bluetooth connection and then placed from the sensor.Signal loss message was not displayed.Therefore, the issue is not confirmed.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: 16098856
• MDR Text Key: 306676440
• Report Number: 2954323-2023-00429
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/20/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2022
• 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