BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6712492 · Received July 13, 2017

    Report

    Report Number
    1000113657-2017-01423
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 21, 2017
    Report Date
    July 13, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006082
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (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. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULT OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 TO 101MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOM. 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 FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 312 AND 308MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS APPROXIMATELY FOUR DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE 403MG/DL (B)(6) 2017 04:30 PM FASTING: YES, THE 372MG/DL (B)(6) 2017 04:27 PM FASTING: YES, THE 391MG/DL (B)(6) 2017 04:20 PM FASTING: YES, THE 201MG/DL (B)(6) 2017 07:00 PM FASTING: YES, THE 214MG/DL (B)(6) 2017 11:40 AM FASTING: YES. CUSTOMER CALLED IN STATING THAT HER METER IS READING HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492819 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2378 00021292006082

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR