BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX GO

    MDR report key: 21942644 · Received May 1, 2025

    Report

    Report Number
    1000113657-2025-00152
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 17, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K143548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 17-JUN-2025: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE RETURNED - TEST STRIPS ARE EXPIRED AT TIME OF PRODUCT RETURN, UNABLE TO BE TESTED (MANUFACTURER'S EXPIRATION DATE IS 30-APR-2025). 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.

    Additional Manufacturer Narrative · 0

    (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 01-MAY-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 245, 211, 362, 297 AND 285 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE BELOW 166 MG/DL AM FASTING AND BELOW 140 MG/DL 2 HOURS POST MEAL. 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 AM FASTING AND PRODUCED TEST RESULT OF 177 MG/DL USING TRUE METRIX GO METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2025 AND TEST STRIPS WERE OPENED 3 DAYS PRIOR TO THE CALL (CUSTOMER HAD BEEN USING A VIAL OF TEST STRIPS WITH THE SAME LOT NUMBER PRIOR TO THE CURRENT VIAL). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 245 MG/DL, DATE: 4/6/2025, TIME: 10:28 PM 2 HOURS POST MEAL. RESULT 2: 211 MG/DL, DATE: 4/6/2025, TIME: 8:19 PM 2 HOURS POST MEAL. RESULT 3: 362 MG/DL, DATE: 4/5/2025, TIME: 12:19 PM 2 HOURS POST MEAL. RESULT 4: 297 MG/DL, DATE: 4/4/2025, TIME: 1:13 PM 2 HOURS POST MEAL. RESULT 5: 285 MG/DL, DATE: 4/3/2025, TIME: 1:12 PM 2 HOURS POST MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208718 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 30CT 24/CASE MG/DL ZB5433S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown