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

Model Number	71857-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported that they are unable to use the application to monitor glucose levels using freestyle libre 2 application (motorola moto g pure (with stylus) phone with android version unspecified operating system).Attempts to replicate the user¿s complaint using a similar configuration was performed and successfully receive high/low glucose alarms on a samsung galaxy a52 (android 13, 2.7.2.7077).Investigation was unable to replicate the complaint therefore, the issue is not confirmed.No malfunction or product deficiency was identified.Smartphone compatibility with the use of freestyle libre 2 and the motorola moto g pure (with stylus) phone 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.This guide is available to the user on the websites where the product is launched.If the product is returned, a physical investigation will be performed, and a follow-up report submitted the device mfg 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 or Problem Description
Abbott diabetes care received a medwatch report which reported the following information: a compatibility issue was reported with an abbott diabetes care (adc) application in use with a motorola moto g pure (with stylus) phone with android version unspecified operating system.Customer was unable to use the application to monitor glucose levels.Adc customer service attempted to contact the reporter three times to gain additional details regarding this event, however all follow up attempts were unsuccessful.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Common Device Name: 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: 17499956
• Report Number: 2954323-2023-34776
• Device Sequence Number: 2394544
• Product Code: QLG
• UDI-Device Identifier: 00357599809003
• UDI-Public: 00357599809003
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71857-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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
• Patient Sex: Unknown