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

Model Number 71992-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 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 experienced excessive bleeding after inserting the adc sensor.Customer was seen at a hospital where unspecified treatment was rendered by a hcp.Customer declined to provide further information.There was no report of death or permanent impairment associated with this event.

Event Description

Customer experienced excessive bleeding after inserting the adc sensor.Customer was seen at a hospital where unspecified treatment was rendered by a hcp.Customer declined to provide further information.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visually inspection has been performed on the returned sensor and no issues were observed.No failure modes were observed upon visual inspection of the plug assembly.No further investigation can be conducted for this particular complaint due to no product returned.If the partial 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.

• 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: 17264017
• MDR Text Key: 318546850
• Report Number: 2954323-2023-28836
• 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: 09/20/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/10/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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