MAUDE Adverse Event Report: ALIVECOR KARDIA MOBILE AND ASSOCIATED WEBPAGE ON ALIVECOR SITE; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Model Number AC-009

Device Problem Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

I use a kardia mobile ecg device from a vendor named, "alivecor".I have been using this device for more than 7 years.During that time i have recorded and saved several ecg tracings which showed an interpretation of "atrial fibrillation".I have found that the alivecor website fails to show these tracings due to a website issue which the company acknowledges.In a recent visit with my provider, i was unable to use this filter to find the af tracings to review with my provider.I believe this is a significant safety issue which the company recognizes but fails to correct.I have noted this issue over a long period of time and it is likely that the vendor has failed to correct a known safety issue.I have contacted alivecor support without adequate resolution.Alivecor has assigned a service id: for your reference, your ticket number is (b)(4).Feel free to reference this request if you wish to contact them on my behalf.Also, i am a health professional with experience in a regulated environment.I am quite certain that this is a serious issue which reflects poor adherence to regulatory requirements on the part of the vendor.I would be happy to discuss by phone or provide additional documents as needed.Thank you.

• Brand Name: KARDIA MOBILE AND ASSOCIATED WEBPAGE ON ALIVECOR SITE
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): ALIVECOR
• MDR Report Key: 16242271
• MDR Text Key: 308173906
• Report Number: MW5114491
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AC-009
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVASTATIN; CARVEDILOL; CLONIDINE; LOSARTAN; MESTINON; NAPROSYN; OMEPRAZOLE
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White