MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 2106070

Device Problems Device Displays Incorrect Message (2591); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

Replaced my abbott freestyle libre 14-day continuous glucose monitor with a new one.The device would not activate and i received this message - "replace sensor your sensor is not working.Please remove your sensor and start a new one".I contacted abbott's support line (b)(4) but the person spoke with such a thick accent as to almost be unintelligible.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12697303
• MDR Text Key: 278786404
• Report Number: MW5104947
• Device Sequence Number: 1
• Product Code: PZE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Lot Number: 2106070
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 66