BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 21841253 · Received April 15, 2025

    Report

    Report Number
    1000113657-2025-00128
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 15, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 288, 234, 131, AND 120 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS FASTING AM 112-120MG/DL AND 1 HR AFTER MEALS 140-150MG/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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE CUSTOMER HAD DISCARDED THE VIAL AND WAS UNABLE TO PROVIDE TEST STRIP LOT INFORMATION; CUSTOMER STATED THE OPEN VIAL DATE IS 1-2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 120 MG/DL DATE: ON (B)(6) TIME: 1:11PM NON-FASTING 1 HR AFTER EATING RESULT 2: 131 MG/DL DATE: ON (B)(6) TIME: 1:09PM NON-FASTING 1 HR AFTER EATING RESULT 3: 142 MG/DL DATE: ON (B)(6) TIME: 7:07PM NON-FASTING 1 HR AFTER EATING RESULT 4: 121 MG/DL DATE: ON (B)(6) TIME: 1:23PM NON-FASTING 1 HR AFTER EATING RESULT 5: 181 MG/DL DATE: ON (B)(6) TIME: 10:41PM NON-FASTING 1 HR AFTER EATING RESULT 6: 234 MG/DL DATE: ON (B)(6) TIME:9:44PM NON-FASTING 1 HR AFTER EATING RESULT 7: 288 MG/DL DATE: ON (B)(6) TIME: 9:41PM NON-FASTING 1 HR AFTER EATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109248 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown