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

Model Number 71926-01

Device Problem Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 08/06/2023

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or 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

Abbott diabetes care received a medwatch report which reported the following information: a nurse reported that after the customer's iphone (unknown model) updated to ios 16.6, the adc application no longer would work.It was indicated that the customer therefore was unaware of a hypoglycemic episode (55 mg/dl from unknown device) and required intervention.The customer was contacted and troubleshooting performed; however, no further information regarding the reported event was obtained.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An investigation has been performed for the freestyle libre 2 complaint and determined that there were no issues with the freestyle libre 2 application that would have led to the complaint.The user reported issues with urgent low glucose alarms on freestyle libre 2 application.Attempted to replicate the user¿s complaint using an iphone 12, 16.4.1, 2.7.2.3589 and was able to successfully receive urgent low glucose alarms in the application 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

Abbott diabetes care received a medwatch report which reported the following information: a nurse reported that after the customer's iphone (unknown model) updated to ios 16.6, the adc application no longer would work.It was indicated that the customer therefore was unaware of a hypoglycemic episode (55 mg/dl from unknown device) and required intervention.The customer was contacted and troubleshooting performed; however, no further information regarding the reported event was obtained.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2 APPLICATION
• 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: 17852586
• MDR Text Key: 324707317
• Report Number: 2954323-2023-43543
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71926-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• 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