BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 20489041 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00063
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    September 12, 2023
    Report Date
    October 12, 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

    EVENT DESCRIPTION THE PATIENT REPORTED THAT THE RESULT FROM THE BLOOD PRESSURE MONITOR WAS 20-30 POINTS HIGHER THAN THE RESULT TAKEN WITH A SPHYGMOMANOMETER. MANUFACTURER NARRATIVE (PROVIDED BY LIVONGO) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229492 LIVONGO BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Prefer Not To Disclose