BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11826796 · Received May 14, 2021

    Report

    Report Number
    1000113657-2021-00314
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 14, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007867
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-069: USING INCORRECT TEST STRIP PLATFORM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 19-APR-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. DAUGHTER STATED THAT SINCE THE LAST CALL, CUSTOMER HAD CONTACTED HIS DOCTOR AND HAD A TELEPHONE CONSULT DUE HIS CONCERN WITH THE RESULTS OBTAINED. THE DOCTOR HAD INCREASED THE CUSTOMER'S INSULIN (IT WAS NOT DISCLOSED BY HOW MUCH).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 279 AND 298 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH RESULTS OBTAINED OF 339 AND 285 MG/DL; TESTS WERE NOT PERFORMED BACK TO BACK. CUSTOMER WAS USING THE INCORRECT TEST STRIPS WITH THE TRUE METRIX METER; CUSTOMER WAS USING TRUE METRIX PRO TEST STRIPS. THE CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. AT THE TIME OF THE INITIAL CALL, MEDICAL ATTENTION WAS 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 03/31/2022 AND OPEN VIAL DATE IS 04/05/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720297 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, PRO TMX HSC 50CTMG/DL ZX4093S 00021292007867

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention