BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7273219 · Received February 15, 2018

    Report

    Report Number
    1000113657-2018-00196
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 15, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    10612479210261
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-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. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER INITIALLY REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. AFTER TROUBLESHOOTING, CUSTOMER ALSO REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 252, 283 AND 205 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 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 ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 243 MG/DL AND 227 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS PRIMARILY CONCERNED WITH THE 252 MG/DL, 283 MG/DL, AND 205 MG/DL READINGS BECAUSE THEY ARE WAY HIGHER THAN HER NORMAL RANGE. CUSTOMER HAD ALSO TAKEN A CONTROL TEST BEFORE AND GOT A 92 MG/DL AND IT DID NOT READ WITHIN THE RANGE OF THE CONTROL SOLUTION LEVEL 2, WHICH WAS 98-132.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118491 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2568 10612479210261

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR