BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23247828 · Received October 8, 2025

    Report

    Report Number
    1000113657-2025-00356
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 31, 2025
    Manufacturer
    SINOCARE INC
    Product Code
    NBW
    PMA / PMN Number
    K231476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. NOTES: 1. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 17-SEP-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. 2. IN MULTIPLE FIELDS THE FORM INDICATES THAT MANUFACTURER RECEIVED PRODUCT, HOWEVER, TRIVIDIA HEALTH, INC. (USA) RECEIVED THE PRODUCT RETURNED AND CONDUCTED THE PRODUCT EVALUATION. 3. SINOCARE (A FOREIGN MANUFACTURER, FEI #3016863723) AND TRIVIDIA HEALTH, INC. (A U.S. COMPANY/IMPORTER, FEI #1000113657) HAVE ENTERED INTO A CUSTOMER SERVICE AGREEMENT. TRIVIDIA HEALTH, INC. HANDLES CUSTOMER COMPLAINTS FOR THE TRUENESS¿ BLOOD GLUCOSE MONITORING SYSTEM AND TRUENESS¿ AIR BLOOD GLUCOSE MONITORING SYSTEM (K231476 - CLASS 2) AND RECORDS CUSTOMER INFORMATION, ESTABLISHING A UNIQUE COMPLAINT NUMBER.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF: 31-OCT-2025. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. IMPORTER'S (THI) RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. SINOCARE'S RETENTION STRIP LOT TESTED WITHIN SPECIFICATION. (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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 140, 143, 145, 134 AND 215 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 87 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 12/11/2026 AND OPEN VIAL DATE IS 08/02/2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 140 MG/DL DATE: (B)(6) 2025 TIME: 4:21 PM FASTING , RESULT 2: 143 MG/DL DATE: (B)(6) 2025 TIME: 6:26 PM FASTING, RESULT 3: 145 MG/DL DATE: (B)(6) 2025 TIME: 3:23 PM FASTING, RESULT 4: 134 MG/DL DATE: (B)(6) 2025 TIME: 1:25 PM 2 HRS. AFTER MEAL , RESULT 5: 215 MG/DL DATE: (B)(6) 2025 TIME: 9:52 PM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565734 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 50CT 4RB286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown