BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23447544 · Received November 3, 2025

    Report

    Report Number
    3016863723-2025-00005
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 20, 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 AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION: PCI RETENTION PENDING, SINOCARE RETENTION PENDING MOST LIKELY UNDERLYING ROOT CAUSE: PENDING NOTES: METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. "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 LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED SHE OBTAINED THE LO ABOUT 20-30 MINUTES AFTER EATING. CUSTOMER STATED SHE PERFORMED A BLOOD TEST USING ANOTHER DEVICE AND OBTAINED A RESULT OF 161 MG/DL NON-FASTING. 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 DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/02/2027 AND OPEN VIAL DATE IS 10/17/2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: LO DATE: 12/23 TIME: 7:06PM NON-FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758401 TRUENESS SYSTEM,TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP,TNS 200CT 30/CS 4RC203 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown