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

Model Number 71992-01

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A sensor error was reported with the freestyle libre 2 sensor.Customer reported receiving a "sensor expired" message on the same day of application and was therefore unable to obtain readings.As a result, customer experienced leg cramps, a seizure, and a loss of consciousness and was unable to self-treat, requiring treatment of glucose via injection by hcp for treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 (serial no) & d4 (expiration date) have been updated based on returned product.H10 (device manufactured date) has been updated based on returned product.Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated and no issues were observed with the returned sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A sensor error was reported with the freestyle libre 2 sensor.Customer reported receiving a "sensor expired" message on the same day of application and was therefore unable to obtain readings.As a result, customer experienced leg cramps, a seizure, and a loss of consciousness and was unable to self-treat, requiring treatment of glucose via injection by hcp for treatment of hypoglycemia.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
• MDR Report Key: 12131386
• MDR Text Key: 260359381
• Report Number: 2954323-2021-74848
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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: 04/30/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 72