MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14-DAY CGM; SENSOR, GLUCOSE, INVASIVE

Lot Number 220126

Device Problems Product Quality Problem (1506); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

I have had a [invalid] of faulty freestyle libre 14-day sensors over the past 6 months.An over 50% failure rate.This has been quite disruptive to my life as i've had to be on the phone for hours trying to get replacements all while not being able to track my glucose as expected.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14-DAY CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14601701
• MDR Text Key: 293502282
• Report Number: MW5110105
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2022
• Device Lot Number: 220126
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BERBERINE; CHLOROPHYLL; FISH OIL; VERAPAMIL
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White