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); Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 12/21/2020

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 review) 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.

Event Description

A high readings issue was reported with the adc freestyle libre 2 sensor.A customer reported receiving unspecified high sensor readings as compared to readings on a competitor meter.The customer self-treated with insulin (dose/type unknown) based on the sensor readings and subsequently experienced symptoms of "tingling on the tongue", dizziness, disorientation, cold sweats, and loss of consciousness.The customer was treated with oral glucose by his co-worker.There was no report of death or permanent injury associated with this event.

Event Description

A high readings issue was reported with the adc freestyle libre 2 sensor.A customer reported, receiving unspecified high sensor readings as compared to readings on a competitor meter.The customer self-treated with insulin (dose/type unknown) based on the sensor readings.And subsequently, experienced symptoms of "tingling on the tongue", dizziness, disorientation, cold sweats, and loss of consciousness.The customer was treated with oral glucose by his co-worker.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) 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).And the sensor was observed to have terminated off of the user's body.The sensor plug was removed.And the plug assembly was inspected, no issues were observed.The sensor was reprogrammed and was not activated.However the sensor remained in sensor state 6.Dspc-20a issue is cloned.An extended investigation was also performed on the returned sensor.A second visual inspection revealed, contamination on the sensor¿s printed circuit board assembly (pcba), due to liquid ingress.The liquid ingress created a short under the asic (application specific integrated circuit), causing irreversible damage to the pcba.Due to the damage, immediate abnormal termination (sensor state 6) occurred.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.Section h6: (investigation findings) code 4247 (appropriate term/code not available) was selected, as adc was unable to perform further testing on the returned device.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: 11088423
• MDR Text Key: 224092068
• Report Number: 2954323-2020-14561
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 01/21/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 96