BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7271003 · Received February 14, 2018

    Report

    Report Number
    1000113657-2018-00187
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 14, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007041
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (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 (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 1/31/2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER RECEIVED THE REPLACEMENT PRODUCT BUT DIDN'T BEGAN TO USE IT YET.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 232, 294, 250, 263 AND 121 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 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 259 MG/DL AND 225 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLING STATES THAT HE RUN SEVERAL BLOOD TEST AND THE RESULTS ARE ERRATIC. CUSTOMER STATES THAT HIS NORMAL GLUCOSE RANGE IS 120-130 MG/DL FASTING. CUSTOMER STATES THAT HE HAD NO CHANGES IN HIS DIET OR MEDICATION. CUSTOMER IS CONCERN WITH THE RESULTS BEING HIGH AND ERRATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113423 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2193 00021292007041

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR