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

Model Number 71992-01-0007

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/06/2024

Event Type  malfunction  

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.Removed the sensor plug and inspected the plug assembly, no failure mode observed.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.Sensor was reprogrammed and simvivo test performed.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: LIBRE 2 SENSOR FREESTYLE
• 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: 19214995
• MDR Text Key: 341417433
• Report Number: 2954323-2024-14905
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-09-30(10)KTP008291(91)71992-01-0007
• Combination Product (y/n): N
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Date Manufacturer Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1