TELADOC BLOOD PRESSURE MONITOR

Description of Event or Problem

ADDITIONAL MANUFACTURER NARRATIVE(PROVIDED BY TELADOC)THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION.SHOULD THIS DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DOCUMENT THE RESULTS OF THE INVESTIGATION. EVENT OR PROBLEM DESCRIPTIONTHE PATIENT REPORTED THAT THE READING FROM THEIR TELADOC BLOOD PRESSURE MONITOR WAS COMPARED TO A MANUAL BLOOD PRESSURE READING TAKEN BY A MEDICAL PROFESSIONAL.THEY STATED THAT THE TELADOC RESULT WAS 180/90, WHILE THE RESULT FROM THE DOCTOR'S MANUAL DEVICE WAS 132/74.THE DIFFERENCE BETWEEN THE READINGS WAS GREATER THAN 20 MMHG.BOTH READINGS WERE TAKEN SIMULTANEOUSLY.

Additional Manufacturer Narrative

CAUSE:WITHOUT THE DEFECTIVE DEVICE FOR RETURN, IT IS CHALLENGING FOR TRANSTEK TO CONDUCT A DETAILED ANALYSIS. THERE ARE SOME SIMILAR DEVICE FAILURES FROM OTHER FEEDBACKS AND THE CAUSE ANALYSIS SHOULD BE THE SAME THEORETICALLY AS BELOW.1. WE CHECKED THE ALL RELATED DHR, INCLUDING MANUFACTURED PROCESS RECORDS, FQC INSPECTION RECORDS, ECT, AND NO ACCURACY ISSUE WAS FOUND.2. THE PRODUCT HAS PASSED CLINICAL VALIDATION ISO 81060-2:2018. ITS PERFORMANCE MEETS THE REQUIREMENTS.PLEASE NOTE:1. IF THE PATIENT COMPARES THE MANUAL READINGS USING DIFFERENT ARMS AT THE SAME TIME, THE METHOD IS INCORRECT AS IT CAN LEAD TO VARIATIONS IN THE READINGS. FOR A VALID COMPARISON, MEASUREMENTS SHOULD BE TAKEN ON THE SAME ARM, ALLOWING A REST INTERVAL OF 1-3 MINUTES BETWEEN READINGS.2.CLINICAL TEST DATA FOR ELECTRONIC BLOOD PRESSURE ALGORITHMS ARE COLLECTED BASED ON STATISTICS AND CAN COVER MOST OF THE POPULATION. HOWEVER, FOR INDIVIDUALS WITH SPECIAL PHYSIOLOGICAL CONDITIONS, SUCH AS THOSE WITH COMMON ARRHYTHMIAS (E.G., ATRIOVENTRICULAR BLOCK, PREMATURE BEATS, OR ATRIAL FIBRILLATION), THE ALGORITHM STRUGGLES TO IDENTIFY STANDARD FLUCTUATION PATTERNS. AS A RESULT, THE EFFECTIVENESS OF THIS DEVICE FOR SUCH USERS HAS NOT BEEN ESTABLISHED.CONCLUSION: THIS ISSUE WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOT A MDR EVENT.