BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 5841535 · Received August 2, 2016

    Report

    Report Number
    1052693-2016-01287
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 8, 2016
    Report Date
    August 2, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/29/2019 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 136MG/DL 07/08/2016 12:00:00 AM FASTING: NO 133MG/DL 07/08/2016 12:00:00 AM FASTING: NO 221MG/DL 07/08/2016 12:00:00 AM FASTING: NO 179MG/DL 07/07/2016 12:00:00 AM FASTING: NO 72MG/DL 07/07/2016 12:00:00 AM FASTING: NO CUSTOMER ALSO COMPLAINED ABOUT RESULTS OF 411MG/DL AND LO, WHICH WERE TAKEN YESTERDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491721 TRUE2GO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUE2GO PT2752

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR