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

Model Number 71732-01

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow-up report will be submitted once additional information is obtained.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 adc device in use with a samsung with android operating system version 2.8.4.9335.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as sweat, dizziness, paleness, no strength and was unable to self-treat.Customer required third-party intervention who provided juice as treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Smartphone compatibility with the use of freestyle librelink app and the samsung galaxy a33 5g device has not been tested at the time of the investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.Attempted to replicate the user¿s complaint using similar configuration and successfully receive high and low glucose alarms on a samsung galaxy a52 (android 13, 2.8.4.9335) using a known good libre 2 sensor, and was unable to reproduce the complaint.Therefore, this complaint 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 with android operating system version 2.8.4.9335.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as sweat, dizziness, paleness, no strength and was unable to self-treat.Customer required third-party intervention who provided juice as treatment.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: 17440248
• MDR Text Key: 320196527
• Report Number: 2954323-2023-33091
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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