MAUDE Adverse Event Report: CARDIA/ALIVECOR ALIVECOR IPHONE 4/4S CASE

Device Problems Incorrect Interpretation of Signal (1543); Device Operates Differently Than Expected (2913)

Patient Problem Anxiety (2328)

Event Date 07/02/2016

Event Type  Injury  

Event Description

I have used the (b)(6) case for several years.It is an fda approved product for the detection of both atrial fibrillation and normal sinus rhythm.Recently the device and software approved by the fda for this purpose have been reporting receiving "excessive noise." however, some readings have resulted in the software algorithm, approved by the fda for the detection of two classes of heart rhythm, as showing atrial fibrillation.I brought the readings to the attention of both the on-call cardiologist and my regular cardiologist.Both interpreted the reading as showing normal sinus rhythm with artifact that was incorrectly labeled as atrial fibrillation.This resulted in me experiencing a panic attack.I have been diagnosed with anxiety conditions dating back many years.I previously had an unreadable ekg produced by the (b)(6) device.I paid for it to be read by a board-certified cardiologist, which is an option through the "app." despite the reading having no p-waves, a perfunctory report was provided by a supposedly board-certified cardiologist saying the rhythm was in sinus rhythm.Due to the error in that report, i had asked for a refund of that reading.Instead the report was provided to the ceo of the company, (b)(6), who diagnosed either atrial flutter or accelerated junctional rhythm.(b)(6) advertises that he is a physician.I later learned that he is not licensed to practice medicine in any state or territory in the united states.I ended up with no board-certified cardiologist based interpretation that i paid for, and i at that time also had to make another doctor's appointment and my doctor again said that the interpretation made by (b)(6) was incorrect.This former incident occurred around (b)(6) 2016.The negative impacts caused by this device have been unnecessary healthcare costs and panic attacks.

• Brand Name: ALIVECOR IPHONE 4/4S CASE
• Type of Device: ALIVECOR IPHONE 4/4S CASE
• Manufacturer (Section D): CARDIA/ALIVECOR
• MDR Report Key: 5795305
• MDR Text Key: 49638537
• Report Number: MW5063402
• Device Sequence Number: 1
• Product Code: DXH
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Weight: 118