BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUENESS

    MDR report key: 23335045 · Received October 20, 2025

    Report

    Report Number
    3016863723-2025-00003
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 18, 2025
    Manufacturer
    SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN
    Product Code
    NBW
    UDI-DI
    00021292015084
    PMA / PMN Number
    K231476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4)-1. B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: HEADACHE AND SHAKINESS. 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 TESTED WITHIN SPECIFICATIONS. RETENTION TESTING WAS ALSO PERFORMED BY THE MANUFACTURER (SINOCARE INC.) USING TEST STRIPS FROM THE SAME LOT. SINOCARE RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(6): INSUFFICIENT BLOOD SAMPLE APPLIED TO STRIP (USER)NOTES: 1. MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. 2. SINOCARE (A FOREIGN MANUFACTURER, FEI #(B)(4)) AND TRIVIDIA HEALTH, INC. (A U.S. COMPANY/IMPORTER, FEI #(B)(4)) 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

    A CONSUMER REPORTED A COMPLAINT REGARDING AN ERROR MESSAGE (E-7). THE CUSTOMER REPORTED FEELING SHAKY AND EXPERIENCING A HEADACHE, BUT MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATIONS IN THE LIVING ROOM. THE TEST STRIP LOT'S MANUFACTURER'S EXPIRATION DATE IS 07/19/2026, AND THE OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER ALSO ADVISED THAT HE PURCHASED 4 CONTAINERS OF TEST STRIPS AND MIXED THE CONTENTS OF THE CONTAINERS TOGETHER. HOWEVER, THE CUSTOMER STATED THAT THE ERROR OCCURRED BEFORE HE MIXED THE TEST STRIPS. THE CUSTOMER DECLINED TO RUN A BLOOD TEST DURING THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300043 TRUENESS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN STRIP, TNS 200CT 30/CS 4R7065 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other