BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 19893088 · Received August 2, 2024

    Report

    Report Number
    1000113657-2024-00319
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 28, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 28-AUG-2024: METER WAS RETURNED FOR EVALUATION TEST STRIPS WERE NOT RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-003: INCONSISTENT TEST METHOD.

    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 STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-003: INCONSISTENT TEST METHOD. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGE (E-5). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 140, 150, 166, 153 AND 258 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 124-127 MG/DL AM FASTING. 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/17/2025 AND OPEN VIAL DATE IS 06/2024. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER PROVIDED RESULTS FROM HER NOTES): TUESDAY ON (B)(6) 2024 ,140MG/DL, AM FASTING . WEDNESDAY ON (B)(6) 2024 ,150MG/DL, AM FASTING. THURSDAY ON (B)(6) 2024 ,166MG/DL, AM FASTING . FRIDAY ON (B)(6) 2024, 153MG/DL, AM FASTING . TODAY ON (B)(6) 2024, 258MG/DL ,AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885522 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZC5625S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown