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

Model Number	71732-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone with android operating system version 13.2.The low glucose alarms did not sound and the customer was not alerted of changes in glucose level.The customer's blood glucose dropped and a family member called emergency services.The customer was unable to self-treat, requiring dextrose capsules provided by non-healthcare professional and glucagon injection administered by healthcare professional as treatment for a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Investigation is pending at this time.A follow up will be submitted once additional information is obtained.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink android application as this report concerns a greece customer.This is same/similar to us freestyle libre 2 android application, model number 71857-01.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.
Additional Manufacturer Narrative
The customer reported for missing low alarms.Sensor was inserted in the simvivo test fixture.The app was downloaded and initial app setup was completed.Sensor was scanned by the app and enabled low glucose alarm feature in the app and set low glucose alarm threshold to highest glucose value.Nano amps was adjusted on the keithley till low glucose alarm was triggered.Alarms functioned as intended.Attempted to replicate customer complaint using similar configuration.However, the reported issue could not be replicated and the system functioned as intended under the tested conditions.Based on the customer¿s reported application, potential causes and device history were also examined, but no issues were identified during replication that could have led to the reported issue.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with unknown phone with android operating system version 13.2 and app version2.11.2.11107.The low glucose alarms did not sound and the customer was not alerted of changes in glucose level.The customer's blood glucose dropped and a family member called emergency services.The customer was unable to self-treat, requiring dextrose capsules provided by non-healthcare professional and glucagon injection administered by healthcare professional as treatment for a diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Common Device Name: DATA MANAGEMENT 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: 20798808
• Report Number: 2954323-2024-46766
• Device Sequence Number: 6833578
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown