MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE; MOBILE ELECTROCARDIOGRAM

Device Problem False Negative Result (1225)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

A user posted a (b)(6) review on (b)(6) 2021, stating that he received a "normal" determination on the device when he was having an atrial fibrillation (afib) episode.User states that "he got a clot from the afib and almost died".

Manufacturer Narrative

User left a (b)(6) review on (b)(6) 2021 claiming an alivecor device showed normal when the user was experiencing an atrial fibrillation (afib) episode: "got a clot from afib and almost died".((b)(4)) user did not specify which alivecor device they were using.Alivecor has attempted to contact the reviewer but was unable to, as (b)(6) doesn't allow sellers to contact users that post (b)(6) reviews unless the reviewer has contacted the seller (alivecor) directly.A false negative afib determination is a known inherent algorithm risk however alivecor has determined that the likelihood of this occurrence is remote.To date, this is the first one that the manufacturer has filed.Taking the review at face value, it does seem that the "normal sinus rhythm" result may have led the customer to delay treatment for afib.As there is no way to contact the user, alivecor cannot retrieve ecgs for analysis or request the device for hardware investigation.Without either ecgs or hardware, alivecor cannot determine if the device malfunctioned or verify whether the customer was actually experiencing an afib episode at the time the recordings were taken, since afib episodes can come and go.

Manufacturer Narrative

User left a (b)(6) review on (b)(6) 2021 claiming an alivecor device showed normal when the user was experiencing an atrial fibrillation (afib) episode: "got a clot from afib and almost died".((b)(4)) user did not specify which alivecor device they were using.Alivecor has attempted to contact the reviewer but was unable to, as (b)(6) doesn't allow sellers to contact users that post (b)(6) reviews unless the reviewer has contacted the seller (alivecor) directly.A false negative afib determination is a known inherent algorithm risk however alivecor has determined that the likelihood of this occurrence is remote.To date, this is the first one that the manufacturer has filed.Taking the review at face value, it does seem that the "normal sinus rhythm" result may have led the customer to delay treatment for afib.As there is no way to contact the user, alivecor cannot retrieve ecgs for analysis or request the device for hardware investigation.Without either ecgs or hardware, alivecor cannot determine if the device malfunctioned or verify whether the customer was actually experiencing an afib episode at the time the recordings were taken, since afib episodes can come and go.

Event Description

A user posted a (b)(6) review on (b)(6) 2021, stating that he received a "normal" determination on the device when he was having an atrial fibrillation (afib) episode.User states that "he got a clot from the afib and almost died".

• Brand Name: KARDIAMOBILE
• 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 ; 6504925856
• MDR Report Key: 12909320
• MDR Text Key: 285223019
• Report Number: 3009715978-2021-00001
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male