BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 13793576 · Received March 17, 2022

    Report

    Report Number
    1000113657-2022-00147
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 16, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS 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. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 01-MAR-2022 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 BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 170, 169, 119 AND 202 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 89-110 MG/DL AND EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115-120 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 PERFORMED BY THE CUSTOMER FASTING PRODUCED TEST RESULT OF 131 MG/DL USING TRUE METRIX AIR METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/19/2022 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 170 MG/DL; DATE: (B)(6) 2022; TIME: 09:37 AM; FASTING. RESULT 2: 169 MG/DL; DATE: (B)(6) 2022; TIME: 09:37 AM; FASTING. RESULT 3: 119 MG/DL; DATE: (B)(6) 2022; TIME: 08:14 AM; FASTING. RESULT 4: 119 MG/DL; DATE: (B)(6) 2022; TIME: 10:56 AM; FASTING. RESULT 5: 202 MG/DL; DATE: (B)(6) 2022; TIME: 08:40 AM; FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368590 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZY4354S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown