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 03/11/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.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, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed and the sensor is properly seated.Visual inspection was performed on the sensor plug assembly and debris near the sensor neck was observed.The sensor tail was also peeled off a bit near the base.The sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly), no evidence of burn marks, electric shock or fire was observed.Extended investigation has also been performed.Additional visual inspection was performed on the pcba and no evidence of burn marks, electric shock or fire was observed.The returned battery was returned intact and no damage was observed.The battery voltage was measured at 1.47v and was found to be within the specification range of (1.45v to 1.60v).The battery voltage is insufficient to cause electric shock therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports an "electric shock" from their adc device.Customer reports feeling the electric shock when moving their arm.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: 13904500
• MDR Text Key: 294038013
• Report Number: 2954323-2022-09969
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/23/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1