BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 5960987 · Received September 19, 2016

    Report

    Report Number
    1000113657-2016-01579
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 27, 2016
    Report Date
    September 19, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 299, 278, 1465, 202 AND 142 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120 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) 2016 A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 242 AND 241MG/DL . THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/21/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER IS TESTING THREE TIMES A DAY (FASTING) AND THE CUSTOMER IS NOT TAKING ANY MEDICATION FOR DIABETES. THE CUSTOMER IS CONTROLLING DIABETES WITH DIET AND EXERCISE. THE CUSTOMER HAS NOT MADE ANY RECENT CHANGES IN HER DIET, EXERCISE REGIMEN, OR MEDICATION. THE CUSTOMER HAD A CUP OF COFFEE WITH STEVIA LESS THAN TWO HOURS PRIOR TO PERFORMING THE BACK TO BACK BLOOD TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611439 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1554

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY