BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18811446 · Received February 29, 2024

    Report

    Report Number
    1000113657-2024-00091
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 29, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    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 WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-057: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-FEB-2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE WILL BRING THE REPLACEMENT PRODUCTS TO HIS NEXT REGULAR SCHEDULED DOCTOR'S VISIT TO CONFIRM THE RESULTS.

    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 173, 190, 172 AND 189 MG/DL. CUSTOMER ALSO STATED THAT THE RESULTS WERE HIGHER COMPARED TO RESULTS OBTAINED USING TRUE BALANCE METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS < 100 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 CUSTOMER'S DESK. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2024 AND OPEN VIAL DATE IS 02/01/2024. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET, CUSTOMER STATED ALL ARE AM RESULTS): RESULT 1: 173 MG/DL DATE: (B)(6) TIME: 12:55PM FASTING RESULT 2: 190 MG/DL DATE: (B)(6) TIME: 12:35PM FASTING RESULT 3: 172 MG/DL DATE: (B)(6) TIME: 12:34PM FASTING RESULT 4: 189 MG/DL DATE: (B)(6) TIME: 12:30PM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170850 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZA5128S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown