BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 24447302 · Received February 25, 2026

    Report

    Report Number
    1000113657-2026-00077
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 25, 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. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. RETENTION TESTING WAS ALSO 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: MLC-006: PASSED OPEN EXPIRATION DATE NOTE: 1. MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER. 2. SINOCARE (A FOREIGN MANUFACTURER, FEI #(B)(4) AND (B)(6). (A U.S. COMPANY/IMPORTER, FEI #(B)(4) HAVE ENTERED INTO A CUSTOMER SERVICE AGREEMENT. (B)(6). 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 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 09/2025. 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
    503734 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