BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23265479 · Received October 10, 2025

    Report

    Report Number
    3016863723-2025-00002
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 10, 2025
    Manufacturer
    SINOCARE INC.
    Product Code
    NBW
    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). THE METER WAS RETURNED, AND PRODUCT EVALUATION IS IN PROCESS. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING AND DETERMINATION OF THE MOST LIKELY UNDERLYING ROOT CAUSE ARE PENDING COMPLETION BY THE PCI TEAM. NOTES: 1. THE MANUFACTURER CONTACTED THE CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2025 TO CONFIRM WHETHER THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN. CONTACT WAS ESTABLISHED WITH THE CUSTOMER, WHO STATED THAT THE REPLACEMENT PRODUCTS HAD ADDRESSED THE INITIAL ISSUE. 2. WHILE MULTIPLE FIELDS IN THE FORM INDICATE THAT THE MANUFACTURER RECEIVED THE PRODUCT, TRIVIDIA HEALTH, INC. (USA) ACTUALLY RECEIVED THE RETURNED PRODUCTS AND WILL CONDUCT THE PRODUCT EVALUATION IN THE COMING DAYS. 3. 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 GL GLUCOSE MONITORING SYSTEM (K231476 - CLASS 2), AND RECORDS CUSTOMER INFORMATION, ESTABLISHING A UNIQUE COMPLAINT NUMBER.

    Description of Event or Problem · 0

    CONSUMER REPORTED A COMPLAINT REGARDING HIGH BLOOD GLUCOSE TEST RESULTS. THE HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED ABOUT THE TEST RESULTS, WHICH WERE 140, 143, 145, 134, AND 215 MG/DL. THE CUSTOMER'S EXPECTED MORNING FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 87 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION WAS SOUGHT AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, THE CUSTOMER DID NOT PERFORM A BACK-TO-BACK BLOOD TEST. THE PRODUCT IS STORED IN THE BEDROOM ACCORDING TO SPECIFICATIONS. THE TEST STRIP LOT HAS A MANUFACTURER'S EXPIRATION DATE OF 12/11/2026, AND THE OPEN VIAL DATE IS ON (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 140 MG/DL, DATE: ON (B)(6) 2025, TIME: 4:21 PM, FASTING. RESULT 2: 143 MG/DL, DATE: ON (B)(6) 2025, TIME: 6:26 PM, FASTING. RESULT 3: 145 MG/DL, DATE: ON (B)(6) 2025, TIME: 3:23 PM, FASTING. RESULT 4: 134 MG/DL, DATE: ON (B)(6) 2025, TIME: 1:25 PM, 2 HOURS AFTER A MEAL. RESULT 5: 215 MG/DL, DATE: ON (B)(6) 2025, TIME: 9:52 PM, NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112470 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC. STRIP,TNS 50CT 4RB286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown