BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6689441 · Received July 6, 2017

    Report

    Report Number
    1000113657-2017-01236
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    January 25, 2016
    Report Date
    July 6, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. 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. RECALL #FDA-ASSIGNED RECALL EVENT ID (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. STRIP EXPIRATION DATE IS 06/30/2018 AND STRIP OPEN DATE IS (B)(6) 2016. STRIP STORAGE IS CORRECT. BACK TO BACK BLOOD TEST PERFORMED NON-FASTING AND RESULTS ARE 200MG/DL AND 190MG/DL REVIEWED METER MEMORY (DATE / TIME NOT SET) THE 176MG/DL (B)(6) 2016 08:47:00 AM FASTING:YES, THE 120MG/DL (B)(6) 2016 07:00:00 PM FASTING:YES, THE 171MG/DL (B)(6) 2015 10:43:00 PM FASTING:YES, THE 188MG/DL (B)(6) 2016 08:51:00 AM FASTING:YES, THE 143MG/DL (B)(6) 2015 06:22:00 AM FASTING:YES. CUSTOMER CALLING CONCERNED HIS METER IS READING LOWER THAN HIS DOCTOR'S METER. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST ON (B)(6) 2016 AT 09:05 AM FASTING AND RECEIVED A RESULT OF 192 MG/DL AND AT THE DOCTOR'S OFFICE USING THE FACILITY METER CUSTOMER RECEIVED A RESULT OF 255 MG /DL . CUSTOMER STATES HIS NORMAL GLUCOSE RANGE IS 132-165 MG /DL FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471825 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2383

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR