BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUENESS

    MDR report key: 25012486 · Received April 28, 2026

    Report

    Report Number
    3016863723-2026-00003
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 1, 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 (THI) RETENTION TESTING WAS NOT RETURNED FOR EVALUATION. IMPORTER'S PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. SINOCARE MOST LIKELY ROOT CAUSE: MLC-055: REFERENCE: COMPETITOR'S METER: THE END OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM NOTE: 1. MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW -UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THE REPLACEMENT PRODUCTS RESOLVED ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME 2. SINOCARE (A FOREIGN MANUFACTURER, FEL # (B)(4) AND TRIVIDIA HEALTH, COMPANY/IMPORTER, FEI # (B)(4) HAVE ENTERED INTO A CUSTOMER SERVICE AGREEMENT. HEALTH, INC. COMPLAINTS FOR THE BLOOD GLUCOSE MONITORING SYSTEM AND TRUENESSTM MONITORING 6- CLASS 2) AND RECORDS CUSTOMER INFORMATION, ESTABLISHING A UNIQUE COMPLAINT NUMBER RETENTION XXX UNDERLYING USER HAD AN INACCURATE USER COMPARING IS RESULTS THE INITIAL CONCERN HANDLES UNABLE TO INC. (A U.S. TRIVIDIA CUSTOMER TRUENESSTM AIR BLOOD GLUCOSE SYSTEM (K231476- CLASS 2) AND RECORDS CUSTOMER INFORMATION, ESTABLISHING A UNIQUE COMPLAINT NUMBER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED WITH CONCERNED WITH THE TESTS RESULTS OBTAINED OF 65MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. DURING THE CALL ON (B)(6) 2026, 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 06/03/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 407 MG/DL DATE: 4/1/2026 TIME:1115AM FASTING (LESS THAN 2HRS AFTER MEAL: NOT CONCERNED WITH HIGH: HAD ICE CREAM) RESULT 2: 150 MG/DL DATE:3/30/2026 TIME:1203PM FASTING AM RESULT 3: 191 MG/DL DATE:3/29/2026 TIME: 1028AM FASTING AM RESULT 4: 49 MG/DL DATE: 3/28/2026 TIME: 628PM FASTING PM (NOT HAVING ANY SYMPTOMS) CUSTOMER STATES THAT BECAUSE OF SLEEP DISORDER AND SLEPT ALL DAY: NOT CONCERNED RESULT 5: 264 MG/DL DATE: 3/27/20206 TIME: 1243PM FASTING PM (FORGOT TO TAKE MEDICATION THE DAY BEFORE-NOT CONCERNED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47788 TRUENESS SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW SINOCARE INC STRIP, TNS 50CT 5R5211 00021292015084

    Patients

    Seq Age Sex Outcome Treatment
    1