MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71733-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.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 unspecified issue was reported with the adc device in use with iphone 7 with ios operating system version 16.3.1.Customer experienced an unexpected application error.As a result, the customer was unable to monitor glucose with sensor readings and experienced dizziness, blank, sweating and was unable to self-treat, requiring treatment of glucose gel by their partner.There was no report of death or permanent impairment associated with this event.

Event Description

An unspecified issue was reported with the adc device in use with iphone 7 with ios operating system version 16.3.1, app version 2.10.1.7653.Customer experienced an unexpected application error.As a result, the customer was unable to monitor glucose with sensor readings and experienced dizziness, blank, sweating and was unable to self-treat, requiring treatment of glucose gel by their partner.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and it has been determined that there were no issues with the librelink application that would have led to the complaint.The customer reported unexpected application error.Successfully scanned and received glucose readings and alarm notifications using similar device configuration.The user complaint could not be reproduced.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: FLASH GLUCOSE MONITORING 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: 17662926
• MDR Text Key: 322417243
• Report Number: 2954323-2023-38295
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201761
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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