BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8520919 · Received April 16, 2019

    Report

    Report Number
    1000113657-2019-00335
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 16, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62 USER HAD POOR TECHNIQUE. TEST STRIP UDI#: (B)(4). NOTE 1: DURING THE CALL EDUCATED CUSTOMER ON BACK TO BACK TESTING TECHNIQUE AND PERFORMED TWO TEST THAT WAS WITHIN RANGE. CUSTOMER AGREES TO CONTINUES TO USE THE PRODUCT AS HIS MAIN CONCERN OF ERRATIC RESULTS HAS BEEN RESOLVED. NOTE 2: MANUFACTURER TRIED TO MAKE CONTACT CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE METER IS WORKING AS INTENDED - UNABLE TO ESTABLISH CONTACT AT THIS TIME. NO PRODUCT NOTIFICATION LETTER SENT SINCE NO CUSTOMER ADDRESS ON FILE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 141, 179 AND 202 MG/DL. CUSTOMER DID NOT USE THE PROPER BACK TO BACK TESTING TECHNIQUE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 125 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 A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 193 MG/DL AND 185 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/16/2020 AND TESTS STRIPS WERE OPENED TWO DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311045 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV3158 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR