MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE 6L; MOBILE ELECTROCARDIOGRAM

Model Number AC-019

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

User posted an (b)(6) review on (b)(6) 2021 stating that they received a 'possible atrial fibrillation" determination on their kardiamobile 6l during a "monomorphic vtach" episode.

Manufacturer Narrative

User left an (b)(6) review on (b)(6) 2021 claiming an alivecor device reported "possible atrial fibrillation" while the user was experiencing "monomorphic vtach".(ticket (b)(4)) the user was able to read his own ecg and sought medical treatment for the condition.As such, there was no delay in treatment.Alivecor cannot contact the reviewer as this (b)(6) review has already been deleted.Additionally, (b)(6) doesn't allow sellers to contact users that post (b)(6) reviews unless the reviewer has contacted the seller (alivecor) directly.Due to the regularity of monomorphic ventricular tachycardia, it is highly unlikely for the kardia algorithm to provide a determination of "possible atrial fibrillation".This remote occurrence could only be possible if there was a large amount of noise present in the signal.To date, this is the first alleged instance of the device interpreting ventricular tachycardia for atrial fibrillation that has been reported.As there is no way to contact the user, alivecor cannot retrieve ecgs for analysis or request the device for hardware investigation.Without either the user's ecgs or hardware, alivecor cannot determine if there was a malfunction.

• Brand Name: KARDIAMOBILE 6L
• Type of Device: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR; 189 n. bernardo ave.; suite 100; mountain view CA 94043
• Manufacturer (Section G): ALIVECOR; 189 n. bernardo ave.; suite 100; mountain view CA 94043
• Manufacturer Contact: susan noriega ; 189 n. bernardo ave.; suite 100; mountain view, CA 94043
• MDR Report Key: 13940528
• MDR Text Key: 288322059
• Report Number: 3009715978-2022-00001
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• PMA/PMN Number: K210753
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AC-019
• Device Catalogue Number: AC-019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• 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