BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7013770 · Received November 9, 2017

    Report

    Report Number
    1000113657-2017-01927
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 17, 2017
    Report Date
    November 9, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 141, 185, 199, 192 AND 256 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 185 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. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 141 MG/DL DATE:(B)(6) 2016TIME: 8:06 PM FASTING, RESULT 2 : 185MG/DL DATE: (B)(6) 2016TIME: 9:34PM FASTING, RESULT 3 : 199 MG/DL DATE: (B)(6) 2016TIME: 8:47PM FASTING, RESULT 4 : 192MG/DL DATE: (B)(6) 2016TIME: 10:30PM FASTING, RESULT 5 : 256 MG/DL DATE: (B)(6) 2016TIME: 8:17 AM FASTING. CUSTOMER IS CONCERNED WITH HIGH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791710 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2464 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR