BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8742095 · Received June 27, 2019

    Report

    Report Number
    1000113657-2019-00688
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 27, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. STRIPS WERE NOT 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 STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    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 207, 185, 232, 182 AND 389 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 150 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 BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 164 MG/DL AND 194 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/13/2020 AND OPEN VIAL DATE IS 05/16/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534635 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV3211 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR