BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 21633987 · Received March 18, 2025

    Report

    Report Number
    1000113657-2025-00090
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    December 30, 2024
    Report Date
    March 18, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED METER: DEFECTIVE LCD/PARTIAL CHARACTERS. TEST STRIPS WERE RETURNED - PER INTERNAL TESTING PROTOCOL, PRODUCT TESTING NOT REQUIRED BASED ON THE PRODUCT FAILURE MODE AS PER FRM-QSR-14-30-01. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. ROOT CAUSE: RC-076: MISHANDLED BY THE END USER. NOTE: MANUFACTURER CONTACTED CUSTOMER IN FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR METER NOT POWERING ON WHEN A TEST STRIP WAS INSERTED. CUSTOMER HAD RECEIVED THE METER 2 MONTHS PRIOR, AND THE BATTERY HAD NEVER BEEN CHANGED. THE CUSTOMER IS USING THE CORRECT BATTERY IN THE CORRECT ORIENTATION FOR THE METER. DURING THE CALL THE TRUE METRIX AIR METER DID NOT POWER ON USING HE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593248 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, TRUE METRIX AIRBLANK MG/DL ZB5407S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown