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 Undesired Nerve Stimulation (1980)

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The customer¿s product has been requested for investigation.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 in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

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

Manufacturer Narrative

Additional information: sections d-4 (expiration date) and h-4 (device mfg date) have been updated.Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and no issues were observed.Visual inspection was performed on the sensor plug assembly and no issues 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 issues were observed.The returned battery voltage was measured to be within specification.The sensor was reprogrammed and activated to perform an accuracy test.The accuracy test was within specification and passed testing.A power consumption test was preformed on the returned battery and was measured to be within specification.It was determined that the battery in the sensor does not have enough voltage to produce an electric shock.No malfunction or product deficiency was identified.This complaint is not confirmed.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports an "electric shock sensation" while wearing an 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: 15943718
• MDR Text Key: 305178230
• Report Number: 2954323-2022-45052
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599800001
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1