BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 11946773 · Received June 7, 2021

    Report

    Report Number
    1000113657-2021-00357
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 7, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER, TEST STRIPS AND CONTROL SOLUTION WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED STRIPS: CONTROL RESULTS OUT OF CONTROL RANGE (HIGH RESULTS). NO DEFECT FOUND ON RETURNED METER AND RETURNED CONTROL. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 186, 154, 128, 172, 145 AND 160 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH RESULTS FROM THE TRUE METRIX METER WHEN COMPARED TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMERS EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-135 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 05/17/2022 AND TEST STRIPS WERE OPENED A FEW DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 186 MG/DL DATE: (B)(6) 2021, TIME: 8:34AM FASTING. RESULT 2: 154 MG/DL DATE: (B)(6) 2021, TIME: 6:40PM FASTING. RESULT 3: 128 MG/DL DATE: (B)(6) 2021, TIME: 8:33AM FASTING. RESULT 4: 172 MG/DL DATE: (B)(6) 2021, TIME: 8:30AM FASTING. RESULT 5: 145 MG/DL DATE: (B)(6) 2021, TIME: 6:38PM FASTING. RESULT 6: 160 MG/DL DATE: (B)(6) 2021, TIME: 8:34AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849831 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZX4133S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1