BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18686564 · Received February 12, 2024

    Report

    Report Number
    1000113657-2024-00059
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 12, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED-REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. 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 30-JAN-2023 TO ENSURE AND TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- CUSTOMER STATES SHE IS COMFORTABLE WITH THE GLUCOSE READINGS FROM THE REPLACEMENT PRODUCTS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CONSUMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON. CUSTOMER STATED THAT LAST WEEK SHE TESTED HER BLOOD SUGAR AT 8:00 AM WITH THE TRUE METRIX AND RESULT WAS 112 MG/DL AND 30 MINUTES LATER SHE WENT TO HER REGULAR CHECKUP APPOINTMENT AND DOCTOR TESTED WITH THEIR BGM AND RESULT WAS 320 MG/DL AM FASTING. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-174 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/18/2025 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 112MG/DL DATE: 1/12 TIME: 8:00AM FASTING. RESULT 2: 170MG/DL DATE: 1/11 TIME: 8:00AM FASTING RESULT 3: 141MG/DL DATE: 1/10 TIME: 8:00AM FASTING RESULT 4: 134MG/DL DATE: 1/09 TIME: 8:00AM FASTING RESULT 5: 136MG/DL DATE: 1/08 TIME: 8:00AM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067523 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZB5331S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown