BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 25055932 · Received May 1, 2026

    Report

    Report Number
    1000113657-2026-00185
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 1, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED: REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-DEC-2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 214, 203, 248 AND 227 MG/DL. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 104-115 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 04/29/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 214 MG/DL, DATE: ON (B)(6), TIME: 2:51AM FASTING. RESULT 2: 203 MG/DL, DATE: ON (B)(6), TIME: 5:09PM UNKNOWN. RESULT 3: 248 MG/DL, DATE: ON (B)(6), TIME: 10:45AM FASTING. RESULT 4: 227 MG/DL, DATE: ON (B)(6), TIME: 10:43AM FASTING. RESULT 5: 107 MG/DL, DATE: ON (B)(6), TIME: 9:37AM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320339 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX KGR 100CTMG/DL ZD6235S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown