BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX GO

    MDR report key: 18494739 · Received January 11, 2024

    Report

    Report Number
    1000113657-2024-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 11, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K143548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER, TEST STRIPS AND CONTROL SOLUTION WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): USER HAD AN INACCURATE REFERENCE. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL TEST AND BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BLOOD GLUCOSE TEST RESULTS OF 154, 151, 160 AND 173 MG/DL AND CONTROL TEST RESULT OF 183 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-114 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/17/2024 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 154MG/DL DATE: (B)(6) TIME: 9:42AM FASTING. RESULT 2: 183 MG/DL DATE: (B)(6) TIME: 11:17AM (CONTROL). RESULT 3: 151 MG/DL DATE: (B)(6) TIME: 9:45AM FASTING. RESULT 4: 160 MG/DL DATE: (B)(6) TIME: 8:53AM FASTING. RESULT 5: 173 MG/DL DATE: (B)(6) TIME: 9:03AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626583 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZA5142S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown