BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11798339 · Received May 10, 2021

    Report

    Report Number
    1000113657-2021-00306
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 15, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    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

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 15-JUN-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-018: USER HAS HIGH GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES ¿ TIRED. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED HER BLOOD GLUCOSE TEST RESULTS WERE IN THE 600'S. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER; CALL WAS DISCONNECTED DURING TRASNSFER OF CALL TO TECHNICIAN. TECHNICIAN HAD ATTEMPTED TO CALL CUSTOMER BUT WAS UNABLE TO CONTACT VIA TELEPHONE; NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693461 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZX4133S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other