BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6704177 · Received July 11, 2017

    Report

    Report Number
    1000113657-2017-01390
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    July 30, 2015
    Report Date
    July 11, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR FILL. BASED ON REVIEW WITH FDA ON 06/21/2017, WE VERIFIED THE AGENCY'S INTERPRETATION OF THE ACT AND SUBMIT THIS MEDWATCH REPORT BASED ON THE NATURE OF THE COMPLAINT FOR THIS RECALLED LOT. FDA-ASSIGNED RECALL EVENT ID 74805.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. CUSTOMER'S EXPECTED RANGE IS 110 AND 125MG/DL. CUSTOMER RAN A BLOOD TEST THIS MORNING AND HIS RESULTS WERE 98MG/DL FASTING, HE THEN HAD BREAKFAST AND MINUTES LATER RAN A BLOOD TEST AND RESULTS WERE 168MG/DL, 30 MINUTES LATER RAN ANOTHER BLOOD TEST AND RESULTS WERE 225MG/DL. CUSTOMER RAN A BLOOD TEST DURING THE CALL AND RESULTS WERE 155MG/DL (NOT FASTING). STRIP EXPIRATION DATE IS 06/16/2018 AND STRIP OPEN DATE IS (B)(6) 2015. STRIP STORAGE IS CORRECT. REVIEWED METER MEMORY: 221MG/DL (B)(6) 2015 04:00:00 AM FASTING:NO; 217MG/DL (B)(6) 2015 03:00:00 PM FASTING:NO; 163MG/DL (B)(6) 2015 02:19:00 PM FASTING:NO; 98MG/DL (B)(6) 2015 01:40:00 PM FASTING:YES; 110MG/DL (B)(6) 2015 11:00:00 PM FASTING:YES. CUSTOMERS CONCERN: 98, 221, 217, 163MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483679 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2371

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR