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); Loss of consciousness (2418)

Event Date 12/03/2022

Event Type  Injury  

Event Description

A high readings issue was reported with use of the adc device.Customer received a higher sensor scan result when compared to result obtained from a competitor brand meter and experienced hypoglycemia and confusion and was unable to self-treat.Paramedic was called and performed a blood glucose test, however no result was obtained as the glucose level was very low.Hcp administration an iv glucose drip, gluco gel, and a peanut butter sandwich.No further treatment was required.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16075858
• MDR Text Key: 306404491
• Report Number: 2954323-2022-47578
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2022

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: 01/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention