BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 22861893 · Received August 21, 2025

    Report

    Report Number
    1000113657-2025-00280
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 21, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND 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-058: 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 ON 15-AUG-2025 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 233, 221, 232, 300 AND 249 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 148 MG/DL USING TRUE METRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2026 AND OPEN VIAL DATE IS 3 DAYS PRIOR TO THE CALL; CUSTOMER STATED THE PREVIOUS VIAL USED HAD THE SAME LOT NUMBER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 233MG/DL , DATE: (B)(6) , TIME: 2:02 P FASTING, RESULT 2: 221MG/DL, DATE: (B)(6) , TIME: 12:39 P FASTING , RESULT 3: 232MG/DL, DATE: (B)(6), TIME: 11:36 A FASTING, RESULT 4: 300MG/DL , DATE: (B)(6), TIME: 9:57 A FASTING , RESULT 5: 249MG/DL , DATE: (B)(6), TIME: 9:54 A FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053786 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 30CT 24/CASE MG/DL ZD6058S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown