BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6181320 · Received December 16, 2016

    Report

    Report Number
    1000113657-2016-02039
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 16, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. (B)(4).

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 181, 217 AND 240 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 140 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 87 MG/DL AND 90 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE COMPUTER ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS AGO. WHEN ASKED ABOUT THE LOW READING OF 74 MG/DL IN THE METER MEMORY, THE CUSTOMER STATED THAT HE WAS LATE IN PICKING UP HIS WIFE SO HE WENT A WHILE WITHOUT EATING SO IT SEEMED ACCURATE. THE CUSTOMER STATED HE IS INSULIN DEPENDENT. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER WAS ASKED ABOUT LOW READING OF 74MG/DL. CUSTOMER STATES THAT HE WAS LATE IN PICKING UP HIS WIFE SO HE WENT A WHILE WITHOUT EATING SO THAT SEEMED ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832368 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1592 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY