MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problems Device Alarm System (1012); Patient Device Interaction Problem (4001)

Patient Problems Purulent Discharge (1812); Erythema (1840); Subcutaneous Nodule (4548); Swelling/ Edema (4577)

Event Date 12/31/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 patient was woken up during the night for multiple hypoglycemia alarms from freestyle libre 3 cgm, which did not correlate with symptoms or fingersticks.Finally, she received an error message from her cgm and then removed it.After removal, there was a lump on her arm which swelled up to size of small cherry and area was red.Pt drained pus from site at home, then applied bacitracin.Pt denies fever, and area is resolving.On (b)(6) 2023 the size of a pea with no redness, but some tenderness when pushing on the site.There is still a knot at the insertion site, but pt notes that she has gotten knots at insertion sites in the past.Pt is appropriately cleaning insertion site by applying cgm after a shower and using alcohol swabs.

• Brand Name: FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16184951
• MDR Text Key: 307634491
• Report Number: MW5114329
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White