BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8103659 · Received November 26, 2018

    Report

    Report Number
    1000113657-2018-01200
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 26, 2018
    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). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE(BATHROOM). TEST STRIP UDI# (B)(4). MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 203, 108, 181 AND 173 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 100 MG/DL. CUSTOMER STATED THAT THE HIGH RESULTS HAVE BEEN HAPPENING FOR THE PAST THREE DAYS. 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) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS BEING STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2020 AND OPEN VIAL DATE IS TWO DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:203MG/DL DATE: (B)(6) 2018 TIME:706AM FASTING; RESULT 2:108MG/DL DATE: (B)(6) 2018 TIME: 423PM FASTING; RESULT 3:77MG/DL DATE: (B)(6) 2018 TIME:153PM FASTING; RESULT 4:181MG/DL DATE: (B)(6) 2018 TIME: 1204PM FASTING; RESULT 5:173MG/DL DATE: (B)(6) 2018 TIME: 746AM FASTING. CUSTOMER RUN A BLOOD TEST AND NOTICE THAT THE RESULT HAVE BEEN HIGH, CUSTOMER STATES THAT HE HAS BEEN SEEING THESE RESULTS FOR THE PAST 3 DAYS . CUSTOMER'S NORMAL GLUCOSE RANGE IS 100MG/DL FASTING AND HE TEST 4 TIMES A DAY CUSTOMER STATES THAT THAT NOTHING HAS CHANGE IN THE HIS DIET OR MEDICATION. STRIPS ARE BEING STORED IN THE BATHROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942541 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2942 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR