BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 25330639 · Received May 29, 2026

    Report

    Report Number
    1000113657-2026-00208
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 29, 2026
    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. IMPORTER'S (THI) RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS PASSED WITHIN SPECIFICATIONS. RETENTION TESTING WAS PERFORMED BY THE MANUFACTURER (SINOCARE INC.) USING TEST STRIPS FROM THE SAME LOT. SINOCARE RETENTION STRIP LOT TESTED WITHIN SPECIFICATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-040: USER'S TEST STRIP HAD POOR FILL. NOTES: 1. MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. 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 LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 120-130 MG/DL AM FASTING AND 180-200 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 NON-FASTING AND PRODUCED TEST RESULT OF LO USING TRUENESS METER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/02/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 3 WEEKS AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377683 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