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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Sweating (2444); Shaking/Tremors (2515)

Event Date 08/05/2020

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 determined that there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kits and the dhrs showed the libre sensor and libre sensor kits 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 no low glucose alarm notification while wearing the adc freestyle libre 2 sensor.On (b)(6) 2020, the customer experienced sweating, crying, shaking, and subsequently lost consciousness.The customer was treated by a non-hcp with an injection of glucagon and oral "gluc up" for their symptoms.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported no low glucose alarm notification while wearing the adc freestyle libre 2 sensor.On (b)(6)2020, the customer experienced sweating, crying, shaking, and subsequently lost consciousness.The customer was treated by a non-hcp with an injection of glucagon and oral "gluc up" for their symptoms.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 was properly seated, and no physical damage was observed on the sensor patch.Data was extracted from the returned sensor using approved software.Sensor found to be in sensor state 5 (indicating normal termination).No failure modes were observed on the sensor plug assembly upon visual inspection.The sensor was activated with a known-good reader to performed the linearity test, and the results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Additional information- section g1: (contact office first name, contact office last name, contact office phone number and contact office email) have been updated from (b)(6) to (b)(6).

• 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: 10875575
• MDR Text Key: 217337158
• Report Number: 2954323-2020-11474
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 78