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 Problems Hypoglycemia (1912); Blurred Vision (2137); Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 02/28/2024

Event Type  Injury  

Event Description

A signal loss was reported with the adc device, and the customer was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced muscle weakness, drowsiness, blurred vision, sweating, dizziness, difficulty concentrating, irritability, and a loss of consciousness.A non-healthcare professional administered a glucagon injection(dose unknown) and provided the customer with sweets for treatment.No further treatment was reported.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 was performed 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 observed.The returned sensor was paired with a known good reader for a communication test.The reader successfully communicated with the returned sensor.A scan timeout error message was not observed.No malfunction or product deficiency was identified.Therefore, this 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: 18981941
• MDR Text Key: 338635740
• Report Number: 2954323-2024-10043
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001033
• UDI-Public: (01)05021791001033(17)241130(10)230918R(91)71994-01
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/20/2023
• 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