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 Hypoglycemia (1912); Cramp(s) (2193); Loss of consciousness (2418)

Event Date 11/21/2020

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 there was no indication that the product did not meet specification.Dhrs (device history record) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle 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.

Event Description

A customer reported a high reading issue with the freestyle libre 2 sensor.The customer reported unspecified high readings, and symptoms of slow reaction, muscle cramps, and loss of consciousness.The customer was treated with glucagon and honey by a third-party, and an ambulance was called.A capillary reading of 4.1 mmol/l was obtained by paramedics, and the customer was given additional glucagon via iv.Comparison readings taken against built-in meter, when plotted on a parkes error grid, fell into the "c" zone, showing the difference in values to be clinically significant.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 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 customer reported a high reading issue with the freestyle libre 2 sensor.The customer reported unspecified high readings, and symptoms of slow reaction, muscle cramps, and loss of consciousness.The customer was treated with glucagon and honey by a third-party, and an ambulance was called.A capillary reading of 4.1 mmol/l was obtained by paramedics, and the customer was given additional glucagon via iv.Comparison readings taken against built-in meter, when plotted on a parkes error grid, fell into the "c" zone, showing the difference in values to be clinically significant.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: 10962850
• MDR Text Key: 220121045
• Report Number: 2954323-2020-12830
• 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

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 57