BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 23598254 · Received November 19, 2025

    Report

    Report Number
    1000113657-2025-00422
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 19, 2025
    Manufacturer
    SINOCARE INC
    Product Code
    NBW
    UDI-DI
    00021292015084
    PMA / PMN Number
    K231476
    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: REPORTED DEFECT NOT REPRODUCED ON RETURNED METER AND STRIP. IMPORTER'S (THI) RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION TESTING WAS PERFORMED BY THE MANUFACTURER (SINOCARE INC.) USING TEST STRIPS FROM THE SAME LOT. SINOCARE RETENTION STRIP LOT TESTED WITHIN SPECIFICATION MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM (B)(4) TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM NOTES: 1. CUSTOMER FOLLOW-UPS CALLS WERE COMPLETED AND UNABLE TO MAKE CONTACT. 2. *SINOCARE (A FOREIGN MANUFACTURER, FEI # (B)(4)) AND (B)(4) (A U.S. COMPANY/IMPORTER, FEI # (B)(4)) HAVE ENTERED INTO A CUSTOMER SERVICE AGREEMENT. (B)(4) 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 LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED SHE OBTAINED THE LO ABOUT 20-30 MINUTES AFTER EATING. CUSTOMER STATED SHE PERFORMED A BLOOD TEST USING ANOTHER DEVICE AND OBTAINED A RESULT OF 161 MG/DL NON-FASTING. 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 BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/02/2027 AND OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: LO DATE: (B)(6), TIME: 7:06PM, NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262879 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 200CT 30/CS 4RC203 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown