BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 16174929 · Received January 16, 2023

    Report

    Report Number
    1000113657-2023-00028
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 16, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 04-JAN-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 152, 394, 185 AND 151 MG/DL. CUSTOMER STATED SHE COMPARED THE TRUE METRIX RESULTS WITH ANOTHER DEVICE AND THE RESULTS WERE HIGHER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER HAD DISCARDED THE VIAL OF TEST STRIPS AND WAS UNABLE TO PROVIDE LOT INFORMATION AND WAS USING A SECOND VIAL; CUSTOMER STATED THAT SHE IS NOT ABLE TO RECOGNIZE WHAT READINGS WERE PERFORMED WITH WHICH VIAL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-120 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-140 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. CUSTOMER STATED THAT VIAL OF TEST STRIPS HAD BEEN OPENED IN 11/2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): RESULT 1: 152 MG/DL, DATE: (B)(6), TIME: 7:45AM, FASTING. RESULT 2: 394 MG/DL, DATE: (B)(6), TIME: 4:30PM, FASTING. RESULT 3: 185 MG/DL, DATE: (B)(6), TIME: 5:30AM, FASTING. RESULT 4: 151 MG/DL, DATE: (B)(6), TIME: 7:54AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363749 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 Unknown