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 Superficial (First Degree) Burn (2685)

Event Date 10/13/2021

Event Type  malfunction  

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 product 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 reported that their adc freestyle libre 2 sensor received an "electric blow when want to scan the sensor and it caused her a burn under the sensor".Customer further reported an "electric shot".There was no report of death, serious injury, or mistreatment associated with this event.

Event Description

Customer reported that their adc freestyle libre 2 sensor received an "electric blow when want to scan the sensor and it caused her a burn under the sensor".Customer further reported an "electric shot".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 (device history review) for the libre sensor and sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor and the sensor plug was observed properly seated.There were no issues observed upon visual inspection.The reported sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.Sim-vivo test was performed, which tests the puck¿s electronics and passed indicating the electronics were working as intended.An extended investigation has also been performed for the returned sensor puck and no abnormalities were observed.The returned puck¿s battery was intact with no damage.The unit battery voltage was measured to be within specifications, and is not sufficient voltage to cause electric shock.No evidence of the reported issue was observed.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported that their adc freestyle libre 2 sensor received an "electric blow when want to scan the sensor and it caused her a burn under the sensor".Customer further reported an "electric shot".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: 12700909
• MDR Text Key: 280804823
• Report Number: 2954323-2021-90097
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1