BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 16278972 · Received February 1, 2023

    Report

    Report Number
    1000113657-2023-00054
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 1, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. ADDED MOST LIKELY UNDERLYING ROOT CAUSE ONTO CASE AS THE COMPLAINT PRODUCT WAS NOT RETURNED FOR INVESTIGATION. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4). 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: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-JAN-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - CALL HAD BEEN DISCONNECTED. MANUFACTURER ATTEMPTED TO CALL BACK TWICE - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 231, 259, 177, 191 AND 181 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-125 MG/DL AND EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT IS > 190 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD GONE TO THE DOCTOR ON (B)(6) 2023 DUE TO GLUCOSE RESULTS OBTAINED. CUSTOMER STATED IT WAS ALSO TO CONFIRM IF PREDNISONE MAY BE CAUSING HER GLUCOSE READINGS TO BE HIGHER THAN EXPECTED. CUSTOMER STATED THE DIAGNOSIS HAD BEEN HIGH BLOOD SUGAR AND THE DOCTOR RESTARTED HER METFORMIN AND INCREASED GLIPIZIDE FROM 5 MG TO 10 MG. 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 CUSTOMER NO LONGER HAD THE TEST STRIPS AND WAS UNABLE TO PROVIDE LOT INFORMATION. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 231 MG/DL, DATE: (B)(6), TIME: 3:08 AM FASTING; RESULT 2: 259 MG/DL DATE: (B)(6), TIME: 3:05 AM FASTING; RESULT 3: 177 MG/DL DATE: (B)(6), TIME: 12:15 AM FASTING; RESULT 4: 191 MG/DL DATE: (B)(6), TIME: 2:44 PM FASTING; RESULT 5: 181 MG/DL DATE: (B)(6), TIME: 9:16 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301176 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 30CT 24/CASE MG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other