BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7136011 · Received December 20, 2017

    Report

    Report Number
    1000113657-2017-02093
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 20, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 171, 136, 184, 211 AND 228MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 130MG/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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAD DIFFICULTY READING TIME AND DATE): RESULT 1:136MG/DL DATE:(B)(6) 2017 TIME:02:03P FASTING, RESULT 2:184MG/DL DATE:(B)(6) 2017 TIME:08:58P FASTING, RESULT 3:211MG/DL DATE:(B)(6) 2017TIME:06:39P FASTING, RESULT 4:228MG/DL DATE:(B)(6) 2017 TIME:03:38P FASTING, RESULT 5:78MG/DL DATE:(B)(6) 2017TIME:10:11P FASTING. CUSTOMER IS ONLY CONCERNED WITH RESULTS ABOVE 130MG/DL TIME AND DATE ARE INCORRECT. CUSTOMER HAD DIFFICULTIES READING THE RIGHT TIME AND DATE CUSTOMER STATES THE METER READ 171MG/DL FASTING.CUSTOMER HAS NOT HAD ANY LAB TESTING IN THE LAST 3 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913244 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2574 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR