BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6698735 · Received July 10, 2017

    Report

    Report Number
    1000113657-2017-01260
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 6, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    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 192, 221 AND 144 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 100 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 288 MG/DL AND 277 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/25/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 192MG/DL (B)(6) 2017 10:22 AM FASTING: YES; 221MG/DL (B)(6) 2017 11:47 AM FASTING: YES; 144MG/DL (B)(6) 2017 10:44 AM FASTING: YES; 198MG/DL (B)(6) 2017 10:36 AM FASTING: YES; 187MG/DL (B)(6) 2017 09:25 AM FASTING: YES. MEMORY CONCERNS: 221 MG/DL AND 192 MG/DL. CUSTOMER CALLED IN STATING HIGH RESULT. CUSTOMER AVERAGE RANGE IS 99-100MG/DL. CUSTOMER FEELS WELL AT THIS TIME AND DENIES NEEDING MEDICAL ASSISTANCE. CUSTOMER IS CONCERNED WITH RESULT: 192 MG/DL AND 221 MG/DL. CUSTOMER STORES STRIPS PROPERLY. CUSTOMER PERFORMED CONTROL TEST AND METER IS TESTING WITHIN RANGE. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST AND FEELS RESULTS ARE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477780 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2151 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR