BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 24289337 · Received February 9, 2026

    Report

    Report Number
    3016863723-2026-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 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. MOST LIKELY UNDERLYING ROOT CAUSE:PENDING COMPLETION. NOTE:FOLLOW-UP CALLS ARE PENDING COMPLETION. SINOCARE(A FOREIGN MANUFACTURER, FEI #3016863723) AND TRIVIDIA HEALTH,INC,(A US.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 UNIQUE COMPLAINT NUMBER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER.THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM BACK-TO-BACK TEST RESULTS OF 93 AND 203 MG/DL. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 164 MG/DL USING TRUENESS METER, PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM, THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 231 MG/DL DATE: (B)(6) 2026 TIME: 11:49AM FASTING (ATE 2 HR. PRIOR) RESULT 2: 277 MG/DL DATE: (B)(6) 2026 TIME: 11:47AM FASTING RESULT 3: 289 MG/DL DATE: (B)(6) 2026 TIME: 11:46AM FASTING RESULT 4: 231MG/DL DATE: (B)(6) 2026 TIME: 1:17PM NON-FASTING RESULT 5: 311 MG/DL DATE: (B)(6) 2026 TIME: 1:16PM NON-FASTING RESULT 6: 93 MG/DL DATE: (B)(6) 2026 TIME: 1:45PM NON FASTING RESULT 7: 203 MG/DL DATE:(B)(6) 2026 TIME: 1:47PM NON FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350927 TRUENESS SYSTEM,TEST BLOOD GLUCOSE,OVER THE COUNTER NBW SINOCARE INC STRIP,TNS 200CT 30/CS 4R6094 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown