BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11856005 · Received May 20, 2021

    Report

    Report Number
    1000113657-2021-00320
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 20, 2021
    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 · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: DIZZY, WEAK, CLAMMY. 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 ERROR MESSAGE (E-0). CUSTOMER'S TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/23/2018; OPEN VIAL DATE WAS NOT DISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF FEELING WEAK, DIZZY AND CLAMMY. CUSTOMER WAS UNABLE TO CONTINUE WITH THE CALL, STATING SHE WAS GOING TO SEEK MEDICAL ATTENTION AND GO TO THE EMERGENCY ROOM. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756363 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS50CT 360/CS MG/DL MT1891 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other