BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 13535957 · Received February 15, 2022

    Report

    Report Number
    1000113657-2022-00074
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 15, 2022
    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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. 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: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 07-FEB-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    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 393, 416, 323, 308 AND 210 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-190 MG/DL AND EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-250 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HE HAD GONE TO THE HOSPITAL ON (B)(6) 2022 WHEN HE HAD OBTAINED THE BLOOD GLUCOSE TEST RESULT OF 308 MG/DL NON-FASTING. AT THE HOSPITAL, CUSTOMER'S BLOOD GLUCOSE TEST RESULTS HAD BEEN 190 AND 200 MG/DL NON-FASTING; TESTS WERE TAKEN ONE HOUR AFTER CUSTOMER HAD OBTAINED THE RESULT OF 308 MG/DL. CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT HAD WAS DISCHARGED THE SAME DAY. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 419 MG/DL USING TRUE METRIX METER; THE CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/22/2023 AND TEST STRIPS WERE OPENED TWO WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777551 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZY4510S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization