BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6120212 · Received November 22, 2016

    Report

    Report Number
    1000113657-2016-01884
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 22, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT #(B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S TEST STRIPS HAD A POOR STORAGE(KITCHEN). NOTE: TEST STRIPS-UDI: (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS.THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 188, 199 AND 237 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99-160 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/23/2017 AND OPEN VIAL DATE IS 10/01/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 188MG/DL (B)(6) 2016 11:32:00 AM FASTING: YES; THE 199MG/DL (B)(6) 2016 11:32:00 AM FASTING: YES; THE 237MG/DL (B)(6) 2016 11:32:00 AM FASTING: YES; THE 187MG/DL (B)(6) 2016 11:32:00 AM FASTING: YES. MEMORY CONCERNS:237 MG/DL. CUSTOMER EDUCATED OF PRODUCT PROPER STORAGE ENVIRONMENTAL CONDITIONS RECOMMENDED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772735 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1818 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY