BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 12026187 · Received June 18, 2021

    Report

    Report Number
    1000113657-2021-00395
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 20, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 20-JUL-2021: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: 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 · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 172, 175, 192, 146 AND 160MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-140MG/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 NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/25/2021 AND OPEN VIAL DATE WAS NOT DISCLOSED. 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 :172MG/DL DATE:5/24/21 TIME:5:50PM FASTING. RESULT 2 :175MG/DL DATE:5/24/21 TIME:5:48PM FASTING. RESULT 3: 192MG/DL DATE:5/24/21 TIME:5:46PM FASTING. RESULT 4: 146MG/DL DATE:5/24/21 TIME:7:50AM FASTING. RESULT 5: 160MG/DL DATE:5/24/21 TIME:7:49AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926069 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL MX4250S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1