BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11864260 · Received May 21, 2021

    Report

    Report Number
    1000113657-2021-00328
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 29, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 29-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-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER CALLED WITH INQUIRY REGARDING RESULT OBTAINED USING THE TRUE METRIX METER, CUSTOMER WAS NOT CONCERNED WITH THE RESULT AND WANTED TO KNOW IF 135MG/DL NON-FASTING WAS A NORMAL TEST RESULT. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758096 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, GNP TMXMETER ONLY MG/DL ZX4243S 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 Other