MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3 APP; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72077-01

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  Injury  

Event Description

Abbott diabetes care (adc) received a medwatch report which reported the following information: an application issue was reported with the abbott diabetes care (adc) device in use with iphone 12 with ios operating system version 17.2.1.A customer was unable to use their freestyle libre 3 application due to their operating system was no longer compatible.The customer reported that there was no adverse heath impact and no report of any self or third-party medical treatment.Adc customer service contacted the customer and they indicated that the issue has been reported and adc offered replacement devices.No further information was provided.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.This complaint was received via user report and has been reported to fda.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The customer reported an incompatible device issue.The reported issue was investigated and attempted to be replicated.Per the abbott diabetes care compatibility guide for the freestyle libre 3 app art44628-004, the reported configuration of ios 17.2.1 is not compatible with freestyle libre 3 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.This is submission report 1 of 3.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The customer reported an incompatible device issue.The reported issue was investigated and attempted to be replicated.Per the abbott diabetes care , the reported configuration is not compatible with freestyle libre 3 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly submitted in the initial report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care (adc) received a medwatch report which reported the following information: an application issue was reported with the abbott diabetes care (adc) device in use with iphone 12 with ios operating system version 17.2.1.A customer was unable to use their freestyle libre 3 application due to their operating system was no longer compatible.The customer reported that there was no adverse heath impact and no report of any self or third-party medical treatment.Adc customer service contacted the customer and they indicated that the issue has been been reported and adc offered replacement devices.No further information was provided.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 3 APP
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18787240
• MDR Text Key: 336291053
• Report Number: 2954323-2024-06855
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223435
• 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: 04/26/2024
• 2 Devices were Involved in the Event: 1 2

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: 72077-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male