BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 15264852 · Received August 22, 2022

    Report

    Report Number
    1000113657-2022-00454
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 22, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 03-AUG-2022 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED IS COMFORTABLE WITH THE GLUCOSE READINGS FROM THE PRODUCT.

    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 193, 180, 191, 153 AND 179 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2022 HE HAD CONTACTED HIS DOCTOR DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THE DOCTOR ADVISED HIM TO HAVE THE METER CHECKED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CUSTOMER'S OFFICE. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2021 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER WAS GOING TO SEE IF HE HAD ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451557 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MW4043S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other