TELADOC BLOOD PRESSURE MONITOR

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.

Description of Event or Problem

EVENT OR PROBLEM DESCRIPTION THE PATIENT REPORTED THAT THEY TOOK THEIR TELADOC BLOOD PRESSURE MONITOR TO THEIR DOCTOR'S OFFICE AND OBTAINED A MANUAL COMPARISON. THE EXACT RESULTS WERE NOT PROVIDED, HOWEVER THE PATIENT CONFIRMED THAT THERE WAS A 20 POINT DIFFERENCE DURING THE SIMULTANEOUS COMPARISON. THE PATIENT CONFIRMED BOTH CUFFS WERE PLACED ON ARMS TO PERFORM THE COMPARISON AT THE SAME TIME. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. ADDITIONAL MANUFACTURER NARRATIVE ( PROVIDED BY TELADOC) THE DEVICE WAS NOT RETURNED FOR THIS INVESTIGATION. SHOULD THE DEVICE BE RETURNED AT A LATER DATE A SUPPLEMENTAL REPORT WILL BE FILED.