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 Fatigue (1849); Hypoglycemia (1912); Sweating (2444)

Event Date 10/05/2020

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 it has been 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 kit were reviewed and the dhrs showed the libre sensor and libre 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

Customer reported receiving a "replace sensor" message after 6 days of wearing an adc freestyle libre sensor and being unable to test.Customer experienced symptoms described as sweating, sleepiness, "heat", and fatigue, and was incapable of self-treating.Customer was treated by a third-party with milk with sugar and no further treatment was reported.There was no report of death or permanent injury associated with this event.

Event Description

Customer reported receiving a "replace sensor" message after 6 days of wearing an adc freestyle libre sensor and being unable to test.Customer experienced symptoms described as sweating, sleepiness, "heat", and fatigue, and was incapable of self-treating.Customer was treated by a third-party with milk with sugar and no further treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh001x4gn0 has been returned and investigated.Visual inspection was performed, and the sensor plug was observed to be properly seated on the mount.Data was extracted from the returned sensor using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with an encryption configuration crc error (event 53) and observed the sensor patch was terminated on the body.An extended investigation was also performed and indicated that the encryption configuration crc error (event 53) occurred due to memory corruption.Therefore, the issue is confirmed due to memory corruption.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
• MDR Report Key: 10681210
• MDR Text Key: 211428541
• Report Number: 2954323-2020-07116
• 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: 04/05/2021

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: 06/30/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 135