BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS AIR

    MDR report key: 24452047 · Received February 26, 2026

    Report

    Report Number
    3016863723-2026-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 11, 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 AND MOST LIKELY UNDERLYING ROOT CAUSE PENDING COMPLETION. NOTES: 1. FOLLOW-UP CALLS PENDING COMPLETION 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 TRUENESSTM BLOOD GLUCOSE MONITORING SYSTEM AND TRUENESSTM 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 CONTROL RESULT OUT OF CONTROL RANGE AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 123, 146, 110 AND 160 MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120 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. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/20/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 4 RESULTS PROVIDED) RESULT: 1: 123 MG/DL DATE: (B)(6) 2026 TIME: 5:38 PM NON-FASTING RESULT 2: 146 MG/DL DATE: (B)(6) 2026 TIME: 5:27 PM NON-FASTING RESULT 3: 110 MG/DL DATE: (B)(6) 2026 TIME: 9:25 PM NON-FASTING RESULT 4: 160 MG/DL DATE: (B)(6) 2026 TIME: 9:23 PM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398435 TRUENESS AIR SYSTEM,TEST,BLOOD GLUCOSE,0VER THE COUNTER NBW SINOCARE INC STRIP,TNS 50CT 5R5072 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown