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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problem Hypoglycemia (1912)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Sensor ((b)(6)) has been returned and investigated.Visual inspection was performed on the returned sensor and no issues were observed.Data was extracted 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.The sensor plug was removed and the plug assembly was inspected, no issues were observed.The sensor was activated with a retained reader and the bluetooth connection was successful.Linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), signal loss message was observed.Since the sensor and reader communicated successfully and a signal loss message was observed after simulating a signal loss, the combination of returned sensor and retained reader were found to be functioning properly; therefore this complaint is not confirmed.No malfunction or product deficiency was identified.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.

Event Description

An alarm issue was reported with the adc device.A customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced symptoms described as "head was heavy" and weakness.The customer was provided apple juice, biscuits, and jelly babies candy for treatment by a non-healthcare professional.There was no report of death or permanent impairment 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: 19177848
• MDR Text Key: 341001215
• Report Number: 2954323-2024-14111
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001033
• UDI-Public: (01)05021791001033(17)250630(10)240207Q(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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/16/2024
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2024
• 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