BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 20489048 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00062
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    July 14, 2023
    Report Date
    September 25, 2023
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: 1. TRANSTEK COULDN'T GET THE COMPLAINT DETAILS FROM END USER AND COULDN'T GET BACK THE DEVICE FOR FURTHER ANALYSIS. 2. NO INVENTORY OF THE SAME MODEL IS FOUND. 3. WE CHECKED THE ALL RELATED DHR, INCLUDING MANUFACTURED PROCESS RECORDS, FQC INSPECTION RECORDS, ECT, AND NO ACCURACY ISSUE WAS FOUND. 4. THE PRODUCT HAS PASSED CLINICAL VALIDATION ISO 81060-2:2018. ITS PERFORMANCE MEETS THE REQUIREMENTS. 5. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER DIDN'T READ THE INSTRUCTIONS CAREFULLY. CORRECTIVE ACTION: 1. ESTABLISH A REGULAR COMMUNICATION MECHANISM WITH CUSTOMERS. 2. PREPARING 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

    MANUFACTURER NARRATIVE (PROVIDED BY LIVONGO). THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR INVESTIGATION. TESTING WAS PERFORMED AND NO FAILURES WERE NOTED. EVENT DESCRIPTION: THE PATIENT REPORTED THAT THEIR BLOOD PRESSURE MONITOR WAS PROVIDING READINGS WITH A VARIANCE WHEN COMPARED TO THEIR PHYSICIAN'S MANUAL CUFF AND A SECONDARY ELECTRONIC BLOOD PRESSURE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229499 LIVONGO BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Prefer Not To Disclose