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

Model Number 71992-01

Device Problem Product Quality Problem (1506)

Patient Problem Electric Shock (2554)

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.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, 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 electric shock from 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 has been performed on the returned sensor and no damage was observed.The senor plug was observed properly seated.No evidence of the reported issue was observed.The returned sensor was sent for further investigation and de-cased.A visual inspection was performed on the de-cased sensor¿s printed circuit board assembly (pcba) and no evidence of fire, smoke, electric shock, or explosion were observed.An extended investigation has also been performed for the returned unit and damaged to the puck was observed.This issue was casued during the de-casing of the the puck; therefore, unable to extract the data nor reprogram the puck due to the damaged.As of result, this issue is unable to test due to damaged puck.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports an electric shock from their adc device.There was no report of death, serious injury, or mistreatment associated with this event.

• 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: 15650152
• MDR Text Key: 307030795
• Report Number: 2954323-2022-38901
• 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
• Report Date: 05/31/2023

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: 02/28/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 02/28/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1