BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6772834 · Received August 7, 2017

    Report

    Report Number
    1000113657-2017-01522
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 7, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62 - USER HAD POOR TECHNIQUE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 147, 181 AND 545 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 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 NON-FASTING AND PRODUCED TEST RESULTS OF 162 MG/DL AND 147 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/21/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 161MG/DL (B)(6) 2017 04:12 PM FASTING: NO, THE 147MG/DL (B)(6) 2017 04:11 PM FASTING: NO, THE 181MG/DL (B)(6) 2017 04:08 PM FASTING :NO, THE 545MG/DL (B)(6) 2017 04:06 PM FASTING: NO, THE 185MG/DL (B)(6) 2017 11:00 PM FASTING: NO. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH THE RESULTS TAKEN ON (B)(6) 2017 CUSTOMER CALLING CONCERN WITH THE METER GIVING ERRATIC BLOOD RESULT. CUSTOMER RUN A BACK TO BACK AND GOT 147/181/545 MG/DL NON FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552422 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2399 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR