BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6911788 · Received October 3, 2017

    Report

    Report Number
    1000113657-2017-01771
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 3, 2017
    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

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT (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. TEST STRIP (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 288MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 140MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 350 AND 344MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/14/2018 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY). 1:194MG/DL (B)(6) 2017 04:29:00 AM FASTING: YES. 2:288MG/DL (B)(6) 2017 04:25:00 AM FASTING: YES. 3:205MG/DL (B)(6) 2017 04:23:00 AM FASTING: YES. 4:143MG/DL (B)(6) 2017 02:29:00 PM FASTING: YES. 5:213MG/DL (B)(6) 2017 04:38:00 AM FASTING: YES. CUSTOMER CALLED IN AND STATES HIS METER IS GIVING HIM INCONSISTENT RESULTS THAT ARE TOO HIGH FOR HIM. CUSTOMER STATES THAT HIS NORMAL FASTING GLUCOSE RANGE IS 110MG/DL-140MG/DL. CUSTOMER IS CONCERNED WITH ALL RESULTS LISTED AND FEELS THAT THEY ARE HIGH FOR HIM. CUSTOMER STATES TIME AND DATE IS INCORRECT IN THE METER. CUSTOMER STATES THAT HIS A1C IS 7.1. CUSTOMER DOES NOT HAVE ANY CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692442 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2275 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR