BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 24571184 · Received March 11, 2026

    Report

    Report Number
    1000113657-2026-00106
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 24, 2026
    Manufacturer
    SINOCARE INC
    Product Code
    NBW
    UDI-DI
    00021292015084
    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 AND TEST STRIPS WERE RETURNED FOR EVALUATION. EVALUATION IN PROCESS. NOTES: 1. MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER. 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 CONTROL RESULT OUT OF CONTROL RANGE AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 123, 146, 110 AND 160 MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120 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. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/20/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 4 RESULTS PROVIDED): RESULT 1: 123 MG/DL DATE: ON (B)(6) 2026 TIME: 5:38 PM, NON-FASTING. RESULT 2: 146 MG/DL DATE: ON (B)(6) 2026 TIME: 5:27 PM, NON-FASTING. RESULT 3: 110 MG/DL DATE: ON (B)(6) 2026 TIME: 9:25 PM, NON-FASTING. RESULT 4: 160 MG/DL DATE: ON (B)(6) 2026 TIME: 9:23 PM, NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629423 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 50CT 5R5072 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown