BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 20489000 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00019
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    October 5, 2022
    Report Date
    October 18, 2022
    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 MEMBER REPORTED ACCURACY CONCERNS WITH THEIR BLOOD PRESSURE MONITOR. MANUFACTURER NARRATIVE (PROVIDED BY LIVONGO). THE MEMBER ALSO REPORTED THAT THEIR PHYSICIAN CHANGED THE DOSAGE OF THEIR MEDICATION, BASED UPON THE READINGS PROVIDED BY THE BLOOD PRESSURE MONITOR, AND SUBSEQUENTLY REVERTED BACK TO A LOWER DOSAGE AS THE NEW ONE WAS TO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261603 LIVONGO BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female