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 11/03/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The reported product has been returned and investigation is pending at this time.A follow-up report will be filed once additional information is obtained.The device manufacturer date for the reported sensor 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.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and no issues were observed.The sensor plug was properly seated in the mount.Visual inspection of the plug assembly and no failures were observed.Visual inspection was performed on the de-cased sensor's pcba (printed circuit board assembly) and no issues were observed.Extended investigation was also performed on the returned sensor.Visual inspection was performed on the returned sensor and no abnormalities were found.The battery was measured at 1.58v and voltage was within specification.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.The customer complained they felt an electrical shock.The puck's battery is rated at 1.6v which is not enough voltage to produce a shock and there was no evidence of a device failure.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports an electric shock while wearing 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: 15845001
• MDR Text Key: 307309531
• Report Number: 2954323-2022-42778
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female