BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 18866388 · Received March 8, 2024

    Report

    Report Number
    1000113657-2024-00103
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 10, 2024
    Report Date
    March 8, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER (B)(4): INITIAL CUSTOMER CALL. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    DURING FOLLOW-UP CALL ON INTERNAL REPORT REFERENCE NUMBER 151047-1, THE CUSTOMER REPORTED MEDICAL INTERVENTION WHILE USING REPLACEMENT PRODUCTS. MANUFACTURER SPOKE WITH CUSTOMER'S ROOMMATE WHO STATED THAT THE CUSTOMER HAD BEEN HOSPITALIZED ON 02/10/2024 AS RESULT OF FEELING WEAK DUE TO DIABETES. ROOMMATE STATED THAT THE CUSTOMER WAS STILL IN THE HOSPITAL AND WOULD BE TAKEN TO A REHABILITATION CENTER. CUSTOMER IS NOT ALLEGING PRODUCT DEFECT; ROOMMATE STATED THAT THE REPLACEMENT METER AND TEST STRIPS WERE WORKING AS INTENDED FOR THE CUSTOMER. ROOMMATE DID NOT PROVIDE PRODUCT INFORMATION (SERIAL NUMBER, LOT NUMBER). NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747967 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization