BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 21735865 · Received March 31, 2025

    Report

    Report Number
    3011420269-2025-00019
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    September 17, 2024
    Report Date
    October 3, 2024
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: OUR IMPORTER TELADOC CONDUCTED AN INVESTIGATION OF THE ORIGINAL BLOOD PRESSURE MONITOR AND FOUND NO ISSUES. THE DEVICE PERFORMED WITHIN ITS SPECIFIED ACCURACY RANGE. FOR TRANSTEK, THERE ARE SOME SIMILAR CLAIMS 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. 3. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER MIGHT NOT READ THE INSTRUCTIONS CAREFULLY. CORRECTIVE ACTION: PREPARE A DOCUMENT CONCERNING TROUBLESHOOTING AND ESSENTIAL PRECAUTIONS AS A NOTIFICATION OF REMINDER FOR CUSTOMER PROMOTION TO MINIMIZE THE RISK OF USER MISOPERATIONS. CONCLUSION: THIS ISSUE WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOT A MDR EVENT. CONDUCTED AN INVESTIGATION OF THE ORIGINAL BLOOD PRESSURE MONITOR AND FOUND NO ISSUES. THE DEVICE PERFORMED WITHIN ITS SPECIFIED ACCURACY RANGE. FOR TRANSTEK, THERE ARE SOME SIMILAR CLAIMS 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. 3. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER MIGHT NOT READ THE INSTRUCTIONS CAREFULLY. CORRECTIVE ACTION: PREPARE A DOCUMENT CONCERNING TROUBLESHOOTING AND ESSENTIAL PRECAUTIONS AS A NOTIFICATION OF REMINDER FOR CUSTOMER PROMOTION TO MINIMIZE THE RISK OF USER MISOPERATIONS. CONCLUSION: THIS ISSUE WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOT A MDR EVENT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: MANUFACTURER NARRATIVE(PROVIDED BY TELADOC) THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS RETURNED FOR INVESTIGATION.THE BLOOD PRESSURE MONITOR PASSED ALL TESTS PREFORMED.THIS INDICAIATES THE BLOOD PRESSURE MONITOR IS PERFORMING AS INTENDED. EVENT DESCRIPTION: THE PATENT REPORTED THAT THEIR LIVONGO BLOOD PRESSURE MONITOR READS 20 POINTS HIGHER COMPARED TO THEIR DOCTORS MANUAL READING TAKEN SIMULTANEOUSLY.THE MEMBER DIDN'T RECEIVE ANY MEDICAL TREATMENT BECAUSE OF THE INACCURATE READING FROM THE TELADOC BLOOD PRESSURE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101232 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown