MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 CGM SENSOR; SENSOR, GLUCOSE, INVASIVE

Lot Number MULTIPLE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Abbott freestyle libre continuous glucose monitor: over the past 4 + months, 8 of 9 sensors have been defective.Three failed to start, two quit well before the advertised 14 days; three gave very low, inaccurate readings (50 or more less than finger stick).Quality control has been abysmal.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 2 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 13395033
• MDR Text Key: 284867139
• Report Number: MW5107081
• Device Sequence Number: 7
• 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: 01/27/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: MULTIPLE
• Patient Sequence Number: 1
• Treatment: METFORMIN
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White