BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 11100391 · Received December 31, 2020

    Report

    Report Number
    1000113657-2020-00939
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 3, 2020
    Report Date
    January 28, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 28-JAN-2021: H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED, AND NO DEFECT FOUND. 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.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED PRODUCT EVALUATION IN-PROCESS. 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 AND STATED IS COMFORTABLE WITH THE RESULTS FROM THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CONSUMER INITIALLY REPORTED COMPLAINT FOR ERROR MESSAGES (E-2) WITH THE CONTROL SOLUTION. CONTROL TEST PERFORMED ON CALL PRODUCED RESULT WITHIN THE ACCEPTABLE RANGE. DURING THE CALL, A BLOOD TEST WAS ALSO PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 319 MG/DL USING METER. CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. CUSTOMER WAS ALSO CONCERNED WITH METER MEMORY RESULTS OF 202, 250, 260, 289 AND 195 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 107-178 MG/DL AND EXPECTED BEFORE DINNER FASTING BLOOD GLUCOSE TEST RESULT IS 200 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2022 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565719 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MX4376S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1