BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11645404 · Received April 9, 2021

    Report

    Report Number
    1000113657-2021-00242
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 4, 2021
    Report Date
    July 9, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS AS OF 09-JUL-2021: CORRECTION ON SECTION B1 TO REMOVE PRODUCT PROBLEM SELECTION SINCE PRODUCT WAS RETURNED AND EVALUATED. INVESTIGATION YIELD NO DEFECT FOUND, THEREFORE THE PRODUCT PROBLEM CATEGORY DOES NOT APPLY.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER SEEKING MEDICAL ATTENTION DUE TO HIGH RESULT AFTER INITIAL CALL. METER AND TEST STRIPS WERE RETURNED - REPORTED DEFECT NOT REPRODUCED. NO DEFECT FOUND 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 16-MAR-2021 2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. CUSTOMER REPORTED MEDICAL ATTENTION SINCE THE LAST CALL, STATING SHE HAD GONE TO THE ER ON (B)(6) 2021. CUSTOMER STATED WHEN SHE TESTED HER BLOOD SUGAR AT HOME, IT WAS IN THE 300¿S NON-FASTING AND SHE WENT TO THE ER WHERE THEY TESTED HER BLOOD GLUCOSE AND IT WAS 191 MG/DL NON-FASTING. CUSTOMER WAS NOT KEPT IN THE HOSPITAL AND WAS TOLD THAT SHE DID NOT NEED MEDICAL ASSISTANCE AND THAT SHE NEEDS TO FOLLOW UP WITH HER DOCTOR.

    Description of Event or Problem · 1

    CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TEST RESULTS OF 124 AND 198MG/DL AND 153, 150 AND 117MG/DL. THE CUSTOMER WAS NOT USING THE PROPER BACK TO BACK TESTING TECHNIQUE. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AT TIME OF CALL. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AT TIME OF CALL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 110MG/DL AND 133MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/22/2022 AND OPEN VIAL DATE IS 03/03/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536799 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMT 50CT24/CASE MG/DL ZX4041S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization