BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 13119244 · Received December 30, 2021

    Report

    Report Number
    1000113657-2021-00812
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 30, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED - REPORTED DEFECT NOT REPRODUCED. NO DEFECT FOUND MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL 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. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 143, 191, 320, 313 AND 333MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140MG/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 291 MG/DL AND 242MG/DL USING TRUE METRIX METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/19/2022 AND OPEN VIAL DATE IS 11/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1 : 143 MG/DL DATE: (B)(6) 2021 TIME: 5:00 PM FASTING, RESULT 2 : 191 MG/DL DATE: (B)(6) 2021 TIME: 4:59 PM FASTING, RESULT 3 : 320 MG/DL DATE: (B)(6) 2021 TIME: 8:15 PM FASTING, RESULT 4 : 313 MG/DL DATE: (B)(6) 2021 TIME: 8:13 AM FASTING, RESULT 5 : 333 MG/DL DATE: (B)(6) 2021 TIME: 8:13 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021110 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, SUNMARK TMX 50CTMG/DL MM ZX4267S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown