BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 11108397 · Received January 4, 2021

    Report

    Report Number
    1000113657-2021-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 9, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 09-FEB-2021: D10/H3/H6: EXPECTED METER WAS RETURNED FOR EVALUATION. PRODUCT EVALUATION RESULTS OF REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. CUSTOMER RETURNED INCORRECT STRIPS MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. POOR TECH-INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCT IS NOT RETURNED FOR INVESTIGATION YET. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 24-DEC-2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THE PRODUCT RESOLVED THE INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 242, 202, 199 AND 220 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-120 MG/DL AND EXPECTED POST-MEAL (3-4 HOURS) FASTING BLOOD GLUCOSE TEST RESULT IS 160 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING (2 HOURS POST MEAL) AND PRODUCED TEST RESULT OF 232 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/13/2022 AND TEST STRIPS WERE OPENED THREE DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5637 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZX4016S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1