MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) 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.

Event Description

A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced pain and bleeding.It was indicated that the customer received unspecified treatment by a third-party.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on returned sensor and no issues were observed.Inspected the plug assembly, no issues were observed.The sensor pack and applicator were not returned, therefore adc is unable to further test the returned product.As submitted in the initial report for this issue, the dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs showed freestyle libre sensor kit passed all tests prior to release.If the partial product is return, a physical investigation will be perform and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced pain and bleeding.It was indicated that the customer received unspecified treatment by a third-party.There was no report of death or permanent impairment 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: 17776906
• MDR Text Key: 323765966
• Report Number: 2954323-2023-41230
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention