BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 19973481 · Received August 13, 2024

    Report

    Report Number
    1000113657-2024-00342
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 13, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. H1: TYPE OF REPORTABLE EVENT OF SERIOUS INJURY IS BEING SUBMITTED DUE TO NO DEFECT BEING FOUND ON RETURNED METER AND TEST STRIPS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 30-JUL-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 143, 173, 181, 189 AND 176 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 140 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED DUE TO THE HIGH RESULTS HE HAD TAKEN THE TRUE METRIX METER TO THE DOCTOR ON (B)(6) 2024 IN ORDER TO COMPARE IT TO THE DOCTOR'S DEVICE. CUSTOMER STATED THE RESULT FROM THE TRUE METRIX WAS 40 POINTS HIGHER; METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/23/2025 AND OPEN VIAL DATE WAS NOT PROVIDED. 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: RESULT 1: 143 MG/DL, DATE: (B)(6) 2024, TIME: CUSTOMER UNABLE TO SEE THE TIME AM FASTING. RESULT 2: 126 MG/DL, DATE: (B)(6) 2024, TIME: 8:47PM FASTING. RESULT 3: 173 MG/DL, DATE: (B)(6) 2024, TIME: 8:45PM FASTING. RESULT 4: 181 MG/DL, DATE:(B)(6) 2024, TIME: 8:43PM FASTING. RESULT 5: 189 MG/DL, DATE: (B)(6) 2024, TIME: 11:28PM FASTING. RESULT 6: 176 MG/DL, DATE: (B)(6) 2024, TIME: 8:13PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640279 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX 100CTMG/DL ECOMMERCE ZC5662S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other