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 02/28/2024

Event Type  Injury  

Event Description

A customer reported a "replace sensor" error message with the adc device and was unable to obtain readings.It was indicated that the customer was provided unspecified treatment by a non-healthcare professional.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6)has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor was found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no failure modes were observed.Sensor was reprogrammed and sim vivo (simulation of the electrical signal produced by the sensor tail) test was performed and 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.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18984032
• MDR Text Key: 338657731
• Report Number: 2954323-2024-10058
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001033
• UDI-Public: (01)05021791001033(17)2025-04-30(10)KTP007877(91)71994-01
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 03/07/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2023
• 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