BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 23324282 · Received October 17, 2025

    Report

    Report Number
    1000113657-2025-00375
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 17, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION; CUSTOMER HAD RETURNED AN EMPTY TEST STRIP VIAL. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-057: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA¿S BGM SYSTEM. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2025 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WAS STILL FEELING NAUSEOUS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2025 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THE NAUSEA HAD IMPROVED BUT THAT SHE HAD A HEADACHE. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 3: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2025 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. CUSTOMER STATED THE REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 188, 247, 223, 227 AND 263 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING NAUSEOUS; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT ON (B)(6) 2025, SHE HAD GONE TO THE HOSPITAL DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER HAD BEEN ADVISED TO CONTACT HER PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED. CUSTOMER TOOK THE METER TO PHYSICIAN'S OFFICE; CUSTOMER'S FASTING BLOOD GLUCOSE TEST RESULT USING THE PHYSICIAN'S METER WAS 208 MG/DL AND WITH THE TRUE METRIX IT WAS 187 MG/DL. PHYSICIAN HAD PRESCRIBED A NEW METER FOR THE CUSTOMER. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/21/2027 AND OPEN VIAL DATE IS 1 WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 188 MG/DL, DATE: ON (B)(6), TIME: 7:33PM FASTING, RESULT 2 :247 MG/DL, DATE: ON (B)(6), TIME: 10:44AM FASTING, RESULT 3: 223 MG/DL, DATE: ON (B)(6), TIME: 7:57AM FASTING, RESULT 4: 227 MG/DL, DATE: ON (B)(6), TIME: 9:02AM FASTING, RESULT 5: 263 MG/DL, DATE: ON (B)(6), TIME: 8:52AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300522 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZD6128S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization