MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number T60000791

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Abbott labs is promoting their freestyle products and we have been having issues with being faulty.We have made five attempts to get the sensors replaced and the call center which is not in the us is not facilitating the issue.We have made several attempts to contact their corporate office with no resolve.Please advise what we should do to prevent the public from buying these faulty items.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16919587
• MDR Text Key: 315229229
• Report Number: MW5117488
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Lot Number: T60000791
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White