MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Lot Number KTP006748

Device Problems Device-Device Incompatibility (2919); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

I use a freestyle libre 2 cgm with a reader.I've tried 4 different sensors in the last 2 days, all of which say the sensor is not compatible with the reader.They are all packaged as freestyle live 2 sensors, 3 from the pharmacy, 1 from abbott as a replacement.When i called customer service, they were familiar with the issue and said some freestyle libre 14 sensors had been mismanaged.There is no info online about this problem.Reference reports: mw5118503, mw5118505, mw5118506.

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17182329
• MDR Text Key: 317791718
• Report Number: MW5118504
• Device Sequence Number: 1
• Product Code: QLG
• 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: 06/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Lot Number: KTP006748
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White, American Indian Or Alaskan Native