BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18985951 · Received March 27, 2024

    Report

    Report Number
    1000113657-2024-00129
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 27, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE RETURNED - CUSTOMER RETURNED EMPTY TEST STRIP VIAL, UNABLE TO TEST (TEST STRIPS ARE ALSO EXPIRED). MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-MAR-2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 192, 200, 354, 209 AND 198 MG/DL. CUSTOMER IS ALSO COMPARING RESULTS TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON TEST RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-113 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2023 AND CUSTOMER STATED HE HAD OPENED THE VIAL OF TEST STRIPS IN (B)(6) 2023. 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: 192 MG/DL DATE: 2/28 TIME: 1:21 PM FASTING AM RESULT 2: 200 MG/DL DATE: 2/14 TIME: 1:40 PM FASTING AM RESULT 3: 354 MG/DL DATE: 2/11 TIME: 1:30 PM FASTING AM RESULT 4: 209 MG/DL DATE: 2/05 TIME: 12:59 PM FASTING AM RESULT 5: 198 MG/DL DATE: 2/01 TIME: 1:36 PM FASTING AM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986147 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX MJR 30CT12/CASE MG/DL ZA4716S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown