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 Problems Bruise/Contusion (1754); Pain (1994); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 11/10/2022

Event Type  Injury  

Event Description

A customer experienced a skin reaction while wearing an adc device and experienced swelling, bruising and severe pain in the arm.Customer had contact with a healthcare professional who diagnosed it as cellulitis and received unspecified treatment.Customer additionally reported being admitted for 4 days in the hospital.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Performed visual inspection on the returned sensor and no issues were observed.The sensor adhesive was returned and intact.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed for the quarterly period during which this complaint unit was manufactured.No abnormalities were found, and the investigation showed all processes were effective.No malfunction or product deficiency was identified.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.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: 15974681
• MDR Text Key: 305412822
• Report Number: 2954323-2022-45686
• 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
• Report Date: 12/14/2022

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: 12/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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