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

Model Number 71992-01

Device Problem Product Quality Problem (1506)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

Customer reports "an electrical like tingle" at the site of the injection of their adc device.There was no report of death, serious injury, or mistreatment associated with this event.

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.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports "an electrical like tingle" at the site of the injection of their adc device.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and no evidence of fire, smoke, electric shock, or explosion were observed.The sensor plug was properly seated in the mount.Visual inspection was performed on the de-cased sensor's pcba (printed circuit board assembly) and no evidence of fire, smoke, electric shock, or explosion were observed.Extended investigation was also performed on the returned sensor.Data was extracted from the sensor using approved software.The sensor was reprogrammed and successful accuracy testing was performed.A thermal camera was used to monitor the sensor while in glucose detection mode, no hot spots on the pcba were observed.No abnormalities were observed.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports "an electrical like tingle" at the site of the injection of their adc device.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and no evidence of fire, smoke, electric shock, or explosion were observed.The sensor plug was properly seated in the mount.Visual inspection was performed on the de-cased sensor's pcba (printed circuit board assembly) and no evidence of fire, smoke, electric shock, or explosion were observed.An extended investigation has also been performed for the returned sensor and no abnormalities were observed.The unit battery voltage was measured to be within specifications.The sensor was reprogrammed and activated to perform an accuracy test.The accuracy test was within specification and passed testing.A thermal camera was used to monitor the sensor while in glucose detection mode, no hot spots were observed.It was determined that the battery in the sensor does not have enough voltage to produce an electric shock, and there was no evidence of a device failure.This complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESYLE LIBRE
• 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: 15379115
• MDR Text Key: 302866942
• Report Number: 2954323-2022-33050
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 12/02/2022; 01/03/2023
• Supplement Dates FDA Received: 12/28/2022; 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1