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

Model Number 71992-01

Device Problem High Readings (2459)

Patient Problems Fall (1848); Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in device manufacture date 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 high readings issue was reported with the freestyle libre 2 sensor.Customer received higher scan results compared to readings obtained on the built-in reader and experienced dizziness, a fall, and a loss of consciousness.Customer was able to self-treat with glucose and had contact with an hcp who obtained a result of 52 mg/dl on their device and treated the customer with additional glucose for a diagnosis of hypoglycemia.A sensor scan result of 267 mg/dl and a comparison result of 119 mg/dl were plotted on a parkes error grid and fell into the c zone, showing the difference in values to be clinically significant.There was no report of death or permanent impairment associated with this event.

Event Description

A high readings issue was reported with the freestyle libre 2 sensor.Customer received higher scan results compared to readings obtained on the built-in reader and experienced dizziness, a fall, and a loss of consciousness.Customer was able to self-treat with glucose and had contact with an hcp who obtained a result of 52 mg/dl on their device and treated the customer with additional glucose for a diagnosis of hypoglycemia.A sensor scan result of 267 mg/dl and a comparison result of 119 mg/dl were plotted on a parkes error grid and fell into the c zone, showing the difference in values to be clinically significant.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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.

Manufacturer Narrative

Sensor 3mh004wn0v0 has been returned and investigated.The sensor plug is fully seated and no issues were observed.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 linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A high readings issue was reported with the freestyle libre 2 sensor.Customer received higher scan results compared to readings obtained on the built-in reader and experienced dizziness, a fall, and a loss of consciousness.Customer was able to self-treat with glucose and had contact with an hcp who obtained a result of 52 mg/dl on their device and treated the customer with additional glucose for a diagnosis of hypoglycemia.A sensor scan result of 267 mg/dl and a comparison result of 119 mg/dl were plotted on a parkes error grid and fell into the c zone, showing the difference in values to be clinically significant.There was no report of death or permanent impairment 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: 12410587
• MDR Text Key: 269436589
• Report Number: 2954323-2021-82644
• 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,Followup
• Report Date: 10/15/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 10/12/2021
• Supplement Dates FDA Received: 09/07/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 127