MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Product Quality Problem (1506)

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

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

The reported product has been returned and investigation is pending at this time.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer initially reported their abbott diabetes care device did not power on.The product was returned and investigated for not powering on, however during investigation burned battery wires were observed.This report is being submitted due to the additional issue observed during returned product investigation.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 19096638
• MDR Text Key: 340029118
• Report Number: 2954323-2024-12454
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001057
• UDI-Public: (01)05021791001057(10)02C151F(91)71983-01
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1