MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE6L; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

I purchased a kardiamobile 6l on (b)(6) 2022 and also paid for the upgrade determinations to track my premature ventricular contractions (pvc).At first the device showed pvcs.About two weeks ago the device started showing normal sinus rhythm.Unfortunately both an echocardiogram and nuclear stress test showed pvcs.The answer i got from alivecor support is my device and operating system isn't compatible with kardiamobile and they can't guarantee correct results.Yet when you purchase the device and download the app there is no warning of what devices have been tested.This is a life threatening situation when the device gives normal sinus rhythm when that isn't the case.Nuclear stress test showed premature ventricular contractions while kardiamobile 6l showed normal sinus rhythm.

• Brand Name: KARDIAMOBILE6L
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): ALIVECOR
• MDR Report Key: 16373027
• MDR Text Key: 309593157
• Report Number: MW5114922
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: METFORMIN
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White