BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 23597750 · Received November 19, 2025

    Report

    Report Number
    1000113657-2025-00420
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO THE PHARMACY FOR ASSISTANCE DUE TO METER RESULTS AND ERROR MESSAGES. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(6): 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 MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-0) AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 323, 252, 263, 211 AND 162 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-126 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE WENT TO THE PHARMACY ON (B)(6) FOR ASSISTANCE; THEY HAD PERFORMED A BLOOD TEST USING CUSTOMER'S TRUE METRIX AIR METER AND HAD OBTAINED A HIGH RESULT. PHARMACY ADVISED HER TO CONTACT MANUFACTURER. CUSTOMER STATED THE DIABETIC EDUCATOR NURSE CAME YESTERDAY; NURSE RAN A BLOOD TEST ON HER METER, DID NOT CLARIFY WHAT THE METER BRAND WAS, AND GOT A RESULT OF 104 MG/DL UNDISCLOSED WHETHER FASTING OR NON-FASTING, NURSE HAD ALSO ADVISED HER TO CONTACT MANUFACTURER. 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 02/28/2027 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 323MG/DL DATE: (B)(6) TIME: 3:08P FASTING. RESULT 2: 252MG/DL DATE: (B)(6) TIME: 1:17P FASTING. RESULT 3: 263MG/DL DATE: (B)(6) TIME: 6:04P FASTING. RESULT 4: 211MG/DL DATE: (B)(6) TIME: 3:29P FASTING. RESULT 5: 162MG/DL DATE: (B)(6) TIME: 02:18P FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362016 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 30CT 24/CASE MG/DL ZD6174S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other