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 Blurred Vision (2137); Sweating (2444); Pallor (2468); Shaking/Tremors (2515)

Event Date 11/22/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving a sensor reading of 329 mg/dl when compared to an unspecified adc meter reading.The results of the reading comparison, when plotted on a parkes error grid, fell into the "c" zone showing the difference in values to be clinically significant.The customer further reported becoming hypoglycemic and experienced symptoms of tremors, sweating, paleness, and blurred vision.The customer was unable to self-treat and received third-party treatment however, no treatment information was provided.The customer further reported being diagnosed with hypoglycemia but no further information was reported.There was no report of death or permanent injury associated with this event.

Event Description

A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A customer reported receiving a sensor reading of 329 mg/dl when compared to an unspecified adc meter reading.The results of the reading comparison, when plotted on a parkes error grid, fell into the "c" zone showing the difference in values to be clinically significant.The customer further reported becoming hypoglycemic and experienced symptoms of tremors, sweating, paleness, and blurred vision.The customer was unable to self-treat and received third-party treatment however, no treatment information was provided.The customer further reported being diagnosed with hypoglycemia but no further information was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs 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.

• 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: 10938225
• MDR Text Key: 219308431
• Report Number: 2954323-2020-12582
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR