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

Model Number 71732-01

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

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 09/02/2023

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device in use with a samsung a23 phone with an android operating system version 13.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 symptoms described as "feeling weak and having hardships being woken up" and was administered an injection of insulin as treatment by a non-healthcare provider.No further information was provided.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 device manufacturing date does not apply.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.

Manufacturer Narrative

An extended investigation was performed.The customer reported missing high and low alarm.Attempted to replicate the customer's complaint using similar configurations (google pixel 4a, android 13, 2.8.4.9335) and the reported issue was unable to be replicated and the system and functioned as intended.There were no issues identified with the freestyle librelink application during replication that would have led to the reported issue.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device in use with a samsung a23 phone with an android operating system version 13 , app version 2849335.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 symptoms described as "feeling weak and having hardships being woken up" and was administered an injection of insulin as treatment by a non-healthcare provider.No further information was provided.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: 17736750
• MDR Text Key: 323279718
• Report Number: 2954323-2023-40334
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 10/31/2023

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: 71732-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• 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