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 Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The reported device has been returned and is currently in process of investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device.The low and high glucose alarms did not sound and the customer was not alerted of changes in glucose level.As a result, the customer experienced loss of consciousness, gloomy feeling, and not feeling well.The customer was seen at a hospital where the customer was diagnosed with hypoglycemia and severe fatigue, but no further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6)has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Reader (b)(6)has been returned and investigated.Visual inspection has been performed on the returned reader and no issues observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and was successful.The current was applied to the sensor to perform linearity testing while in the test fixture.Reader settings were configured through masterm.Both high and low glucose alarms were successfully activated.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.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.Dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader 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 abbott diabetes care (adc) device.The low and high glucose alarms did not sound and the customer was not alerted of changes in glucose level.As a result, the customer experienced loss of consciousness, gloomy feeling, and not feeling well.The customer was seen at a hospital where the customer was diagnosed with hypoglycemia and severe fatigue, but no further information was provided.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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19036501
• MDR Text Key: 339292892
• Report Number: 2954323-2024-11100
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-06-30(10)KTP007731(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,Followup
• Report Date: 04/26/2024

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: 03/27/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2023
• 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
• Patient Sex: Male