BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX GO

    MDR report key: 11661240 · Received April 13, 2021

    Report

    Report Number
    1000113657-2021-00254
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 13, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K143548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. NO METER TESTING REQUIRED. THE METERS ARE NOT MANUFACTURED BY, NOT MANUFACTURED FOR AND NOT MARKETED BY TRIVIDIA HEALTH, INC. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055 USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: THIS COMPLAINT EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (B)(6).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. COMPLAINT WAS SUBMITTED BY SINOCARE ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULT OBTAINED OF 4.9 MMOL/L FASTING; CUSTOMER COMPARED THE RESULT OBTAINED OF 4.9 MMOL/L TO RESULT OBTAINED FROM BIOCHEMISTRY ANALYSER OF 6.1 MMOL/L. CUSTOMER HAD ALSO PERFORMED FASTING METER TO METER COMPARISON TESTS AND HAD OBTAINED RESULT OF 6.2 MMOL/L USING TRUEMETRIX GO METER AND 7.3 AND 6.8 MMOL/L USING ANOTHER DEVICE; AND 5.4 MMOL/L USING TRUEMETRIX GO METER AND 6.6 AND 6.9 MMOL/L USING ANOTHER DEVICE. THE CUSTOMER DID NOT REPORT SYMPTOMS AND NO MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2021; STORAGE CONDITIONS AND THE OPEN VIAL DATE ARE UNKNOWN. THE LAST FIVE METER MEMORY RESULTS WERE PROVIDED: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557839 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP 50CT SINOCARE TMXMMOL/L MX4357SSNC

    Patients

    Seq Age Sex Outcome Treatment
    1