MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71733-01

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

Patient Problem Hyperglycemia (1905)

Event Date 08/15/2023

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device in use with iphone 11 with ios operating system version 16.2.1.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 nova rapid was administered for treatment.There was no report of death or permanent impairment associated with this event.

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.

Manufacturer Narrative

The reported issue was attempted to be replicated using similar configurations.The reported issue was unable to be replicated and the system functioned as intended.There were no issues identified with the freestyle librelink app 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 iphone 11 with ios operating system version 16.2.1.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 nova rapid was administered for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• 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: 17698658
• MDR Text Key: 322833606
• Report Number: 2954323-2023-39405
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/02/2023

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: 71733-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention