MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC LIBRE 2 SENSOR FREESTYLE; DATA MANAGEMENT SYSTEM

Model Number 71992-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

The customer¿s product data has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device mfg date is unknown.The date entered 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) application in use with an android operating system.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and was unable to self-treat, requiring third-party treatment of "liquid to raise sugar" (type/dose unspecified) by a healthcare professional.There was no report of death or permanent injury associated with this event.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) application in use with an android operating system.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and was unable to self-treat, requiring third-party treatment of "liquid to raise sugar" (type/dose unspecified) by a healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs 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.Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Both high and low glucose alarms were successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: LIBRE 2 SENSOR FREESTYLE
• Type of Device: DATA MANAGEMENT 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: 16425691
• MDR Text Key: 310041843
• Report Number: 2954323-2023-07806
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160030
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71732-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention