BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 6741332 · Received July 25, 2017

    Report

    Report Number
    1000113657-2017-01471
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    July 3, 2017
    Report Date
    July 25, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292001018
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4) 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 HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI, 433 AND 259 MG/DL (NOT FASTING). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 97 - 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)2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS (B)(6)2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): A 433MG/DL (B)(6)2017 12:00 PM FASTING:NO. A 161MG/DL (B)(6)2017 12:00 PM FASTING:NO. A 178MG/DL (B)(6)2017 12:00 AM FASTING:NO. A 259MG/DL (B)(6)2017 12:00 PM FASTING:NO. HI (B)(6)2017 12:00 PM FASTING:NO. MEMORY CONCERNS:HI, 433, 259, 178, 161MG/DL. TIME NOT VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521822 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RT5029 00021292001018

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR