BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 20075892 · Received August 27, 2024

    Report

    Report Number
    1000113657-2024-00362
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 27, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 AN NO DEFECT FOUND ON RETURNED METER. 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 12-AUG-2024 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 214, 210, 243, 178 AND 197 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULTS ARE 90 MG/DL AM FASTING AND 130 MG/DL PM NON-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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE CUSTOMER NO LONGER HAD THE VIAL OF TEST STRIPS WAS UNABLE TO PROVIDE LOT INFORMATION. CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS, LOT NUMBER ZC5737S, MANUFACTURER'S EXPIRATION DATE OF 01/18/2026. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 120 MG/DL USING TRUE METRIX AIR METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 214 MG/DL, DATE: 8/02/2024, TIME: 9:00AM NON-FASTING AM; RESULT 2: 210 MG/DL, DATE: 8/01/2024, TIME: 8:56PM FASTING PM; RESULT 3: 243 MG/DL, DATE: 8/01/2024, TIME: 8:56PM FASTING PM; RESULT 4: 178 MG/DL, DATE: 8/01/2024, TIME: 1:49AM FASTING AM; RESULT 5: 197 MG/DL, DATE: 7/28/2024, TIME: 10:38PM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219576 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown