BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6913748 · Received October 4, 2017

    Report

    Report Number
    1000113657-2017-01776
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 4, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006068
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT (B)(4) PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62- USER HAD POOR TECHNIQUE. TEST STRIP (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 364, 111 AND 99 MG/DL. CUSTOMER IS ALSO CONCERNED THAT THE RESULT OF 364 MG/DL IS TOO HIGH. CUSTOMER IS CONCERNED WITH ERRATIC READINGS DUE TO INSULIN DEPENDENCY. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF ALCOHOL PRODUCTS TO CLEAN FINGERS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 130 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 99 MG/DL AND 95 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE COMPUTER ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/19/2018 AND OPEN VIAL DATE IS WITHIN ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:96MG/DL (B)(6) 2017 08:00 AM FASTING: YES.2:174MG/DL (B)(6) 2017 04:32 PM FASTING: YES.3:126MG/DL (B)(6) 2017 04:31 PM FASTING: YES.4:99MG/DL (B)(6) 2017 04:29 PM FASTING: YES.5:111MG/DL (B)(6) 2017 04:28 PM FASTING: YES.MEMORY CONCERNS: 364MG/DL.CUSTOMER CALLED IN AND STATED THAT HER METER IS GIVING HER ERRATIC RESULTS. CUSTOMER STATES SHE HAD NECK SURGERY TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693284 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2230 00021292006068

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR