MAUDE Adverse Event Report: INFOBIONIC INC. MOME KARDIA; ARRHYTHMIA DETECTOR AND ALARM

Model Number	01854
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient affected by the event was enrolled and was monitored in a clinical research study for 29 days.To suppress billing and usage statistics, which were not desired for this study, the demo mode for software was set.In addition to suppressing these features statistics, the demo mode also allows for the upload of simulated patient data for a particular patient day, provided no other patient data has been received for that day.The patient turned off the device on last day of the monitoring, before all stored data had been transmitted, and began the process of returning the device to the practice.The device had not yet transmitted any data for the last day when it was turned off.Three days later, a monitoring technician noticed that no data had been transmitted for the last day.Since there was no data for the last day yet available, and the practice was set to demo mode, an "upload data" button was visible.The "upload data" button allows for simulated/demo data to be uploaded for any patient day containing no other data.A software feature that allows the technician to see how much data remains to be transmitted from a patient device was not used, and the technician pressed the "upload data" button under the mistaken assumption that this would cause the real patient data to be uploaded from the patient device.Instead, simulated data was uploaded for that day, and an atrial fibrillation arrythmia event was created and reported from the simulated data.Later the device was physically received back at the practice and turned on.The device then began uploading its stored data and overwrote/removed the simulated data uploaded for the last day.The monitoring technician noticed the error when preparing the final report and notified the physician on the research team.The physician then communicated the error and provided correct diagnosis to the patient and his physician.No therapy was administered to the patient as a result of initial incorrect diagnosis.
Event or Problem Description
A product malfunction event was reported by healthcare professional on a phone call regarding a patient who was monitored under a clinical research study.A set of simulated patient data (demo data) had been uploaded to actual patient record data inadvertently and was interpreted as actual patient data at the time of initial diagnosis.This product malfunction caused the research study patient to be incorrectly diagnosed with atrial fibrillation when initial diagnosis was done.The patient and his physician were notified of this incorrect diagnosis.One of the monitoring technicians, while finalizing the patient report later, noticed the error and notified the physician on the research team.The physician on the research team notified the patient and his physician of the error and provided correct diagnosis.No therapy was administered to the patient based on the initial incorrect diagnosis.No patient injury or harm was resulted as an outcome of the event.The simulated data was later successfully removed and original correct data was restored intact.

• Brand Name: MOME KARDIA
• Common Device Name: ARRHYTHMIA DETECTOR AND ALARM
• Manufacturer (Section D): INFOBIONIC INC.; 200 5th avenue; suite 4030; waltham MA 02451
• MDR Report Key: 11296106
• Report Number: 3010112812-2021-00001
• Device Sequence Number: 3368796
• Product Code: DSI
• UDI-Device Identifier: B690MK10
• UDI-Public: +B690MK10
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01854
• Device Lot Number: 092020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 71