KARDIA ALIVECOR PERSONAL EKG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for KARDIA ALIVECOR PERSONAL EKG manufactured by Alivecor.

Event Text Entries

[59224617] Problem, alivecor is counting t waves in its ekg and doubling heart rates into the danger zone as a result in their kardia consumer facing ekg app/hardware https://app. Alivecor. Com/ note: i was an emt in college and work in health info coaching startups so i am unusually well informed and comfortable with new technology and self directed health care but this could have been a serious problem for anyone else. I love my alivecor ekg but doubling a hr is an error and sending out a red box warning immediate physician eval from their paid cardiology service is a big enough concern that i feel obligated to report it. The fix is simply to put a warning on that the ekg can often oversample t waves and ensure that the cardiologists who read it note that this is happening and not frighten people into unneeded emergency health care. When using a kardia / alivecor personal ekg on 11:03pm on (b)(6) after a run and shower. It showed a heart rate of 229 beats per minute. If i had believed it i might have called 911. On (b)(6), at 11:13pm i paid to have it read by one of their tech and at 11:16pm their report indicated sinus tach with no notes that the hr was really only 130 or so, by then my hr was 65 so i wasn't concerned. (b)(6) at 9am, since i wasn't sure what had happened or if this was an urgent problem or not so i scheduled an urgent appt to see my family practice doctor at 2:45 and she called me back at lunch time to discuss. In the meantime i researched ekgs and realized that it was counting the t waves as a beat and effectively doubling the rate. I reported the error to alivecor via their online form on (b)(6) at 9:36am. (b)(6) at 10:16am, i paid to have an alivecor/kardia cardiologist review the ekg report online. (b)(6) around noon i spoke to my family practice doctor at (b)(6) and she suggested a referral to a cardiologist without seeing the ekg (she had an earlier one from (b)(6) that also overcounted by 50%). I will now be subjected to add'l probably unneeded stress, testing and costs. (b)(6) at 10am to 4:45pm, i continued to try and reach alivecor via phone call and called them 3 times throughout the day but as of today (b)(6) haven't heard back. (b)(6) 2:43pm, i received the report from the alivecor cardiologist with a red box warning - immediate physician eval strongly advised. Have appt for acupuncture at teaching hospital so decided to wait. (b)(6) at 5pm reached out to alivecor ceo (b)(4) via (b)(6) via a dm to alert him to the problem - told him to consider it a safe table exercise. (b)(6) at 6pm posted the ekg online asked quant self friends for feedback. Asking how many beats per minute. (b)(6), 7:12pm, dr. (b)(6) responded "divide by 2. The t-waves are as large as the qrs complexes, this is a problem shared by many ecg machines. It's called t-wave over sensing. " (b)(6) at 7:30 went for previously scheduled acupuncture treatment (b)(6) - had them read ekg, check hr and bp, they agreed it was doubling hr and my bp and hr 60 were fine. Removed the public posting of my ekg 9 pm. (b)(6) at 10:33 am, sent a f/u email to alivecor asking them to respond to my concerns at the systems level (vs personal) alerting them of my and my doctors concerns and the possibility of filing an fda report. Note: on (b)(6), there was also an incident with the software/hardware that indicated i was i afib with an hr of 177. That is the ekg that dr (b)(6) had a copy of (b)(6). The kardi doctor (paid for in addition to the app) advised "forward this report to your physician within 24 hrs, for his/her advice regarding further eval. " it was simple sinus tach. Both times that my hr has been over 100 it has indicated a medical problem when there wasn't one and double counted my hr as a result of oversampling t waves.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065771
MDR Report Key6075282
Date Received2016-11-01
Date of Report2016-11-01
Date of Event2016-10-30
Date Added to Maude2016-11-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKARDIA ALIVECOR PERSONAL EKG
Generic NameKARDIA ALIVECOR PERSONAL EKG
Product CodeDXH
Date Received2016-11-01
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALIVECOR


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-01

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