BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX GO

    MDR report key: 16985410 · Received May 23, 2023

    Report

    Report Number
    1000113657-2023-00288
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 20, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K143548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO CLINIC DUE TO METER RESULTS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-MAY-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 20-JUN-2023: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 346 MG/DL USING TRUE METRIX GO METER AND 245 MG/DL USING ANOTHER DEVICE AND FROM RESULTS OBTAINED OF 233, 226, 243 AND 279 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE; CUSTOMER HAS BEEN RECENTLY DIAGNOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER HAD GONE TO THE CLINIC DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER HAD OBTAINED 346 MG/DL FASTING USING THE TRUE METRIX GO METER AND THE RESULT AT THE CLINIC 15MIN LATER HAD BEEN 245 MG/DL FASTING. CUSTOMER HAS NOT YET FOLLOWED UP WITH HIS PHYSICIAN. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/17/2024 AND OPEN VIAL DATE IS (B)(6) 2023. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 346. MG/DL DATE: (B)(6). TIME: 3:25PM. FASTING BEFORE LUNCH RESULT 2: 233 MG/DL. DATE: (B)(6). TIME: 11:02AM. FASTING RESULT 3: 226 MG/DL. DATE (B)(6). TIME: 7:14PM. FASTING BEFORE DINNER RESULT 4: 243 MG/DL. DATE: (B)(6). TIME: 11:22AM. FASTING RESULT 5: 279 MG/DL. DATE: (B)(6). TIME: 9:22PM. FASTING BEDTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257009 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZA5142S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other