BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23675557 · Received November 28, 2025

    Report

    Report Number
    3016863723-2025-00011
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    July 28, 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 RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH BLOOD READINGS. NO DEFECT FOUND ON RETURNED METER. IMPORTER'S (THI) RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATION. RETENTION TESTING WAS PERFORMED BY THE MANUFACTURER (SINOCARE INC). USING TEST STRIPS FROM THE SAME LOT. SINOCARE RETENTION STRIPS TESTED WITHIN SPECIFICATION. ROOT CAUSE: RC-072: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME. 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, NOTE 2. IN MULTIPLE FIELDS THE FORM INDICATES THAT MANUFACTURER RECEIVED PRODUCT HOWEVER, TRIVIDIA HEALTH, INC. (USA) RECEIVED THE PRODUCT RETURNED AND CONDUCTED THE PRODUCT EVALUATION. NOTE 3. SINOCARE (A FOREIGN MANUFACTURER, FEI # 301683723) 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, 118 AND 124 MG/DL. THE CUSTOMER'S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-100 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, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 3 RESULTS PROVIDED): RESULT 1: 122 MG/DL DATE: (B)(6) 2025 TIME: 8:09 AM FASTING RESULT 2: 118 MG/DL DATE: (B)(6) 2025 TIME: 7:58 AM FASTING RESULT 3: 124 MG/DL DATE: (B)(6) 2025 TIME: 9:44 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054847 TRUENESS SYSTEM,TEST BLOOD GLUCOSE,OVER THE COUNTER NBW SINOCARE INC. STRIP,TNS 200CT 30/CS 4R6099 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown