BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 16278847 · Received February 1, 2023

    Report

    Report Number
    1000113657-2023-00053
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 1, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO SYMPTOM (DIZZY). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED AND MOST LIKELY UNDERLYING ROOT CAUSE SELECTED. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4). NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-JAN-2023 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (UNKNOWN). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 113, 106, 108, 123 AND 133 MG/DL. CUSTOMER ALSO WAS COMPARING TO ANOTHER DEVICE AND STATED THE TRUE METRIX RESULTS WERE LOWER. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER STATED SHE FELT DIZZY. CUSTOMER STATED THAT A MONTH AGO (EXACT DATE NOT PROVIDED) SHE HAD ALSO FELT DIZZY AND HAD GONE TO HER DOCTOR. CUSTOMER STATED SHE HAD BEEN TOLD HER BLOOD GLUCOSE WAS HIGH AND WAS PRESCRIBED A NEW MEDICATION. DURING THE CALL, 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 07/31/2022 (EXPIRED). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 113 MG/DL, DATE: 1/4/2023, TIME:643AM FASTING; RESULT 2: 106 MG/DL, DATE: 1/3/2023, TIME:1056PM FASTING; RESULT 3: 108 MG/DL, DATE: 12/28/2022, TIME: 703PM FASTING; RESULT 4: 123 MG/DL, DATE: 12/27/2022, TIME: 958AM FASTING PM; RESULT 5: 133 MG/DL, DATE: 12/23/2022, TIME: 610PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300345 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 25CT24/CS MG/DL #383237 MX4429S 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other