BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 6560224 · Received May 11, 2017

    Report

    Report Number
    1000113657-2017-00823
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 21, 2017
    Report Date
    May 11, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292008642
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER NO LONGER HAS ANY SYMPTOMS AND NO MEDICAL ATTENTION IS REPORTED. CUSTOMER RECEIVED REPLACEMENT PRODUCT. CUSTOMER SATISFIED WITH THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 TO 150 MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF HEADACHE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2009 (EXPIRED) AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). PATIENT CONTACTED US ON READINGS BEING HIGH. THE TEST STRIPS AND CONTROL SOLUTIONS ARE EXPIRED. CUSTOMER HAS BEEN USING EXPIRED TEST STRIPS FOR A FEW DAYS AND RECEIVING HIGH RESULTS. CUSTOMER SAYS HER NORMAL GLUCOSE RANGE IS 102-150 MG/DL. PATIENT TESTS TWICE DAILY. CUSTOMER IS HAVING A HEADACHE BUT DOES NOT NEED MEDICAL ATTENTION AT THIS TIME. VERIFIED METER MEMORY RESULTS NONE OF THE RESULTS WERE FASTING RESULTS. THE CUSTOMER WILL PURCHASE TEST STRIPS AND CONTACT US BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342696 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RH2469 00021292008642

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY