MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71992-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 12/15/2023

Event Type  Injury  

Event Description

An email was received reporting an alarm issue with the adc device in use with unknown phone with unknown operating system.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer was seen at a hospital where unspecified treatment for hypoglycemia was provided.Adc has attempted to contact the customer to obtain additional information regarding the med event, however all attempts up to this point have been unsuccessful.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Extended investigation is pending at this time.A follow up 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 does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The freestyle librelink complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing high and low glucose alarms.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An email was received reporting an alarm issue with the adc device in use with unknown phone with unknown operating system and unknown app version.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer was seen at a hospital where unspecified treatment for hypoglycemia was provided.Adc has attempted to contact the customer to obtain additional information regarding the med event, however all attempts up to this point have been unsuccessful.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• 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: 18413816
• MDR Text Key: 331576841
• Report Number: 2954323-2023-55443
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/21/2024

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?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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