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 Hypoglycemia (1912); Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/24/2021

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 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 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 the low glucose alarm failed to trigger with the freestyle libre 2 sensor.As a result, the customer experienced symptoms of cramping and a loss of consciousness.An ambulance was called and upon arrival, the customer was diagnosed with hypoglycemia and he believed to have been given glucose injection as treatment.No further information was provided.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 was performed and no physical damage is observed on sensor patch.Sensor plug was properly seated in the mount.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Set the low glucose threshold in the alarm settings.Activated sensor with a known good reader and performed accuracy test.Low glucose alarms were successfully activated.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported the low glucose alarm failed to trigger with the freestyle libre 2 sensor.As a result, the customer experienced symptoms of cramping and a loss of consciousness.An ambulance was called and upon arrival, the customer was diagnosed with hypoglycemia and he believed to have been given glucose injection as treatment.No further information was provided.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: 12563615
• MDR Text Key: 274319263
• Report Number: 2954323-2021-86639
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2021
• 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
• Patient Sex: Male
• Patient Weight: 82 KG