BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23335113 · Received October 20, 2025

    Report

    Report Number
    3016863723-2025-00004
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 18, 2025
    Manufacturer
    SINOCARE INC
    Product Code
    NBW
    UDI-DI
    00021292015084
    PMA / PMN Number
    K231476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER, TEST STRIPS AND CONTROL SOLUTION WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED 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. NOTES: 1. IN MULTIPLE FIELDS THE FORM INDICATES THAT MANUFACTURER RECEIVED PRODUCT, HOWEVER TRIVIDIA HEALTH, INC. (USA) RECEIVED THE PRODUCTS RETURNED AND WILL BE CONDUCTING THE PRODUCT EVALUATION ON THE COMING DAYS. 2. 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.

    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 122, 123, 107, 126 AND 93 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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 09/03/2026 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 122 MG/DL DATE: ON (B)(6) 2025 TIME: 9:14AM FASTING AM RESULT 2: 123 MG/DL DATE: ON (B)(6) 2025 TIME: 4:52PM FASTING AM RESULT 3: 107 MG/DL DATE: ON (B)(6) 2025 TIME: 9:22AM FASTING AM RESULT 4: 126 MG/DL DATE: ON (B)(6) 2025 TIME: 8:26AM FASTING AM RESULT 5: 93 MG/DL DATE: ON (B)(6) 2025 TIME: 8:07AM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2766076 TRUENESS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 50CT 4R8219 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown