MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 08/15/2022

Event Type  Injury  

Event Description

Freestyle libre started to hurt today.I sanitized the skin as instructed before application but adhesive rim became loose and today i developed swelling and white discharge at the application site.I had several malfunctioning devices before, when sensor does not register with reader, but i did not have an infection until today.Quality of this product deteriorated.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15249943
• MDR Text Key: 298339361
• Report Number: MW5111563
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXIN; LIPITOR ; MAGNESIUM OXIDE; METFORMIN ; MULTIVITAMINS
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic
• Patient Race: White