MAUDE Adverse Event Report: ALIVECOR, INC. KARDIAMOBILE; MOBILE ELECTROCARDIOGRAM

Model Number	AC-009
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969); Neck Pain (2433)
Date of Event	04/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alivecor received a complaint from user/patient where it appears that the user while experiencing a heart attack recorded an ecg and received device algorithm analysis of "normal sinus rhythm".The patient did not delay seeking medical attention due to the kardiamobile result and rushed to the emergency room.Alivecor's kardiamobile is a lead-i mobile ecg device that is not intended to detect heart attacks.The device labeling specifies that the device does not detect heart attacks.For investigation, the ecg from the user was sent to a cardiologist for review and analysis.The cardiologist concurred with kardiamobile determination and confirmed that the ecg from the user was indeed in normal sinus rhythm.Based on the investigation results, alivecor concluded that the device had not malfunctioned because it performed as intended, did not cause or contribute to the heart attack, and the incident was a result of user error.
Event or Problem Description
Patient contacted alivecor on (b)(6) 2020 stating that she used kardiamobile to take ekg and received normal sinus rhythm determination while experiencing a heart attack.The specific comments from the patient notes that "on (b)(6), i started having chest pain, left arm/shoulder pressure/pain, neck and jaw pain.I had not used the kardia unit in a while and had to update the app on my phone.After more than few attempts i got a reading that said normal ekg.".

• Brand Name: KARDIAMOBILE
• Common Device Name: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR, INC.; 444 castro street; suite 600; mountain view, ca
• MDR Report Key: 10084224
• Report Number: 3009715978-2020-00002
• Device Sequence Number: 3083638
• Product Code: DXH
• UDI-Device Identifier: B210AC0090
• UDI-Public: +B210AC0090
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AC-009
• Device Catalogue Number: AC-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2020
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization