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 09/23/2022

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 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 electric shocks on their arm while wearing an adc device.There was no report of death, serious injury, or mistreatment associated with this event.

Event Description

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

Manufacturer Narrative

Additional information: section d4 (serial no) has been updated from (b)(6) section d4 (device expiry date) & h4 (device mfg date) have been updated based on the returned product download.Sensor (b)(6) has been returned and investigated.A visual inspection was performed on the returned sensor and no issues were observed.The sensor plug was properly seated.The customer reported experiencing an electric shock with the sensor, and no issues were observed during the investigation.The returning sensor was investigated further and de-cased.A visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.The returned battery was measured and was not within specification.Replaced the returned battery with a new unused battery and reprogrammed the sensor.Performed a functionality test and all of the results were in specification.The battery used in the sensor does not supply enough voltage to create a electrical shock.Therefore, this issue is not confirmed.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.All pertinent information available to abbott diabetes care has been submitted.

• 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: 15636148
• MDR Text Key: 306686367
• Report Number: 2954323-2022-38688
• Device Sequence Number: 1
• Product Code: QLG
• 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: 05/11/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR