BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 18282091 · Received December 7, 2023

    Report

    Report Number
    1000113657-2023-00590
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    October 27, 2023
    Report Date
    December 7, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-072: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 09-NOV-2023 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 143, 124, 118 AND 147 MG/DL. THE CUSTOMER'S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 114 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 123 MG/DL USING TRUE METRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/17/2023 AND TESTS STRIPS WERE OPENED ONE MONTH PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): RESULT 1: 143 MG/DL , DATE: (B)(6) 2023 , TIME: 3:52 AM FASTING. RESULT 2: 124 MG/DL DATE: (B)(6) 2023, TIME: 3:50 AM FASTING. RESULT 3: 118 MG/DL,, DATE: (B)(6) 2023, TIME: 4:23 AM FASTING RESULT 4: 118 MG/DL , DATE: (B)(6) 2023, TIME: 4:22 AM FASTING. RESULT 5: 147 MG/DL , DATE: (B)(6) 2023, TIME: 4:20 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127566 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZA4777S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown