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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  Injury  

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to a "replace sensor" message displaying on the same day of sensor application.Due to delivery delay, customer was unable to test and required unspecified treatment via third-party.There was no report of death or permanent impairment associated with this event.

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.The sensor was found to be in sensor state 5 (indicating normal termination).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.Additional testing has been performed for this issue and poise voltage testing was within specification, indicating the sensor was providing accurate glucose readings.All results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• 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: 18997363
• MDR Text Key: 338875095
• Report Number: 2954323-2024-10411
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-07-31(10)KTP007885(91)71992-01-0006
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention