BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7189403 · Received January 15, 2018

    Report

    Report Number
    1000113657-2018-00061
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 15, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00010939719447
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS 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. (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 12/29/2017 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    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 180, 160, 265, 189 AND 144 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 125 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 127 MG/DL AND 156 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE FAMILY ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1:180MG/DL DATE:(B)(6) TIME:11:46AM FASTING, RESULT 2:160MG/DL DATE:(B)(6) TIME:11:46AM FASTING, RESULT 3:265MG/DL DATE:(B)(6) TIME:11:23AM FASTING, RESULT 4:189MG/DL DATE:(B)(6) TIME:11:22AM FASTING, RESULT 5:144MG/DL DATE:(B)(6) TIME:8:47AM FASTING. CUSTOMER IS CONCERNED WITH BOTH THE HIGH RESULTS AND THE ERRATIC RESULTS FROM THE METER. TIME NOT CURRENTLY SET UP CORRECTLY IN THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34924 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2541 00010939719447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR