BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18632619 · Received February 2, 2024

    Report

    Report Number
    1000113657-2024-00038
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 5, 2024
    Report Date
    February 2, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    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). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO CLINIC DUE TO METER RESULTS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER AND STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK AM FASTING TEST RESULTS OBTAINED 2 WEEKS AGO OF 172, 204 AND 149 MG/DL AND FROM AM FASTING RESULTS OBTAINED OF 141, 152 AND 116 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 98-110 MG/DL FASTING AM AND WHEN HE EATS SUGAR THE DAY BEFORE <147MG/DL AM FASTING; CUSTOMER CONFIRMED THAT HE DID NOT HAVE SUGAR MEALS THE DAY BEFORE THESE TESTS WERE PERFORMED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE WENT TO THE CLINIC DUE TO CONCERN WITH THE TRUE METRIX METER RESULTS. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN TESTED AT THE CLINIC HAD BEEN 96 MG/DL FASTING. NO FURTHER INFORMATION WAS PROVIDED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/15/2024 AND OPEN VIAL DATE IS CLOSE TO ONE MONTH. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622629 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX TPC 50CT24/CASE MG/DL ZB5242S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other