MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE; MOBILE ELECTROCARDIOGRAM

Model Number AC-009

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

User contacted alivecor on (b)(6) 2023 alleging that his kardia device detected "atrial fibrillation" while he was experiencing ventricular tachycardia.(ticket (b)(4) he also reported a delay of treatment due to the "atrial fibrillation" determination which he did not constitute as a medical emergency.Alivecor contacted the user (b)(6) 2023 and (b)(6) 2023 to investigate the allegation.The customer responded (b)(6) 2023 and provided details into his experience.(b)(6) 2023, the customer suddenly felt weak and sweaty, and he could not feel his pulse.He took his ecg on his kardiamobile device, and got the result of "atrial fibrillation" with a heart rate of 226 bpm.He packed a bag, contacted a ride sharing service, waited approximately 10 minutes, selected a hospital that wasn't the nearest, was dropped off at the main entrance then walked to the er.He believes this was a total delay of about 30 to 40 minutes.In the hospital, he was diagnosed with ventricular tachycardia and was cardioverted, which resolved the ventricular tachycardia.He stayed at the hospital for a couple of days for observation and was given amiodarone to control his rhythm.Since then, he has not experienced any further episodes.Dr.David albert (founder of alivecor and a trained cardiologist) analyzed the customer's ecg taken during the episode on june 20, 2023.He determined that it was most likely ventricular tachycardia, although there was a possibility that it was atrial fibrillation through an accessory pathway which has a similar appearance on an ecg to ventricular tachycardia.He also noted that the ecg had low amplitude, which caused inaccurate r-r intervals.This situation likely caused the kardia algorithm to determine that the rhythm was irregular which led to the false positive "atrial fibrillation" determination.However, the calculated heart rate of 226 bpm was accurate.At the date of this filing, the user has not yet returned his kardiamobile device for manufacturer evaluation; however, the clean ecg recording and correct heart rate calculation leads alivecor to conclude that there was likely no hardware malfunction during the episode.Kardia is not indicated or fda cleared to detect ventricular tachycardia.The kardiamobile reported the accurate heart rate of 226 bpm but the expected kardia determination for this ecg would have been "unclassified." regardless of whether the underlying arrhythmia is atrial fibrillation or ventricular tachycardia, the heart rate of 226 bpm is a pathological condition that constitutes an emergency for virtually anyone.The user's perception that atrial fibrillation is not an emergency may have caused him to delay his treatment.This customer did not experience a serious injury due to the delay.

Event Description

Alivecor user received an "atrial fibrillation" determination when he was in ventricular tachycardia and reported a delay of treatment.

• Brand Name: KARDIAMOBILE
• Type of Device: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR; 189 north bernardo ave.; suite 100; mountain view CA 94043
• Manufacturer (Section G): ALIVECOR; 189 north bernardo ave.; suite 100; mountain view CA 94043
• Manufacturer Contact: samip ; 189 north bernardo ave. suite 100; mountain view, CA 94043
• MDR Report Key: 17916862
• MDR Text Key: 326817506
• Report Number: 3009715978-2023-00001
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AC-009
• Device Catalogue Number: AC-009
• Date Manufacturer Received: 07/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male