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 07/13/2022

Event Type  malfunction  

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

No product has been returned, extended investigation is pending at this time.A follow- up report will be submitted 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

An extended investigation has been performed for the reported complaint and it has been 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.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and the senor plug were observed properly seated.No physical damage is observed on sensor patch.The returned sensor was de-cased and visual inspection was performed on printed circuit board assembly (pcba) and no issues were observed.Performed sim vivo testing ( testing puck¿s electronics) on the returned sensor and the test passed.Visual inspection was performed on the internal components of the sensor and no damage found.The returned puck¿s battery was intact with no damage and measured within specification.The puck¿s battery produces voltage that is insufficient to produce an electric shock.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: 15108665
• MDR Text Key: 296676551
• Report Number: 2954323-2022-25752
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1