BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX PRO

    MDR report key: 18055133 · Received November 2, 2023

    Report

    Report Number
    1000113657-2023-00538
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 2, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007867
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO CLINIC (PHARMACY) DUE TO METER RESULTS AND ERROR MESSAGES. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. 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-009: USE ERROR CAUSED OR CONTRIBUTED TO EVENT. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2023 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-0, E-4 AND E-6) USING TWO DIFFERENT VIALS OF TEST STRIPS; INTERNAL REPORT REFERENCE (B)(4). CUSTOMER IS USING TRUE METRIX PRO PRODUCTS WHICH ARE DESIGNED FOR PROFESSIONAL USE. CUSTOMER STATED HE IS UNABLE TO DETERMINE WHICH RESULTS HE OBTAINED USING EACH VIAL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 202, 223, 214 AND 250 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS <130 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE METER RESULTS AND ERROR MESSAGES HE HAD GONE THAT MORNING ( (B)(6) 2023) TO THE CLINIC (PHARMACY). CUSTOMER STATED THE PHARMACIST HAD ATTEMPTED TO ASSIST BUT HAD THEN ADVISED THE CUSTOMER TO CONTACT THE MANUFACTURER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/22/2024 AND TEST STRIPS WERE OPENED 1-2 WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 202 MG/DL DATE: (B)(6).TIME: 6:15AM FASTING AM ON (B)(6) 2023. RESULT 2: 223 MG/DL DATE: (B)(6) TIME: 6:14AM FASTING AM ON (B)(6) 2023. RESULT 3: 214 MG/DL DATE: (B)(6) TIME: 8:22PM FASTING PM ON (B)(6) 2023. RESULT 4: 250 MG/DL DATE: (B)(6) TIME: 8:21PM FASTING PM ON (B)(6) 2023. RESULT 5: 145 MG/DL DATE: (B)(6) TIME: 8:35PM FASTING PM ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131838 TRUE METRIX PRO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX PRO50CT MG/DL ZB5249S 00021292007867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other