BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8270466 · Received January 23, 2019

    Report

    Report Number
    1000113657-2019-00056
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 27, 2018
    Report Date
    January 24, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = T) INTERNAL REPORT # 01611468 RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-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. TEST STRIP UDI#: (B)(4). NOTE: UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE AT CALL BACKS ON 01/03/2019, 01/07/2019 AND 01/10/2019. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 232, 190 AND 212 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 - 205 MG/DL. CUSTOMER WAS USING CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SHAKY AND NAUSEOUS. CUSTOMER WAS GOING TO CONTACT HER PHYSICIAN. DURING THE CALL ON 12/27/2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/23/2020 AND OPEN VIAL DATE IS 12/25/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:232MG/DL, (B)(6), 10:54AM, FASTING; RESULT 2:190MG/DL, (B)(6), 10:40AM, FASTING; RESULT 3:212MG/DL, (B)(6), 10:39AM, FASTING; RESULT 4:185MG/DL, (B)(6), 9:28AM, FASTING.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: LAB RESULTS: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIAS'S BGM SYSTEM TO THE RESULTS FROM THE LABORATORY. (B)(4). UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE AT CALL BACKS ON (B)(4) 2019. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 232, 190 AND 212 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 - 205 MG/DL. CUSTOMER WAS USING CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SHAKY AND NAUSEOUS. CUSTOMER WAS GOING TO CONTACT HER PHYSICIAN. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/23/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63423 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV3015 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY| SECOND THERAPY