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 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

The reported product has been returned and investigation is pending.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 device did not power on.The product was returned and investigated for not poweing on, however during investigation the device became hot while charging.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.Issues involving thermal events occurring with adc freestyle libre and libre 2 readers is associated with report of corrections and removal number 2954323-02/09/23-001-c, submitted to the fda on 09-feb-23.Adc field action fa1005-2023 was issued to the us 09feb23.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19109268
• MDR Text Key: 340225532
• Report Number: 2954323-2024-12713
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: (01)00357599803001(10)03D067D
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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: 08/23/2023
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR869779
• Patient Sequence Number: 1