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

Model Number 71992-01

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection was performed on the returned sensor, no issues were observed.Sensor plug was properly seated in the mount.Data was extracted using approved software, sensor was found to be in sensor state 6 (indicating abnormal termination).The sensor plug was removed and the plug assembly was inspected, no issues were observed.The sensor was reprogrammed, the battery was replaced, and data was extracted again, however the sensor remained in sensor state 6.An extended investigation was also performed on the returned sensor.A visual inspection on the printed circuit board assembly (pcba) revealed extensive corrosion and attempts to reprogram the sensor were unsuccessful.In order to test the complaint of high readings, a linearity test must be performed, however since the damage to the pcba was so extensive, a linearity test could not be performed, and the voltage could not be monitored.Adc was therefore unable to perform further testing related to the high readings issue reported by the customer.A separate investigation into the abnormal termination (sensor state 6) was performed (which was noted to have occurred at the time of the investigation and was not part of the customer¿s original complaint.) it was observed that the sensor was in state 6 with event code 21 (indicating a temporary drop in the source voltage) and the sensor was observed to have terminated on the body.The sensor was de-cased and corrosion was found, therefore the abnormal termination was attributed to corrosion.No further investigation is required.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A high readings issue was reported with the adc freestyle libre 2 sensor.A customer obtained readings of 475 mg/dl, 474 mg/dl, 447 mg/dl, with no comparative readings, and self-treated with fast-acting insulin (dose unknown).The customer noticed he reached low glucose levels and was taken to the hospital.The customer obtained a laboratory result of 46 mg/dl, was diagnosed with hypoglycemia, and treated with glucose drip.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: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 10901282
• MDR Text Key: 218191605
• Report Number: 2954323-2020-11825
• 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
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/02/2020
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 93