BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9224998 · Received October 23, 2019

    Report

    Report Number
    1000113657-2019-10090
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 25, 2019
    Report Date
    May 8, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). SECTIONS WITH ADDITIONAL INFORMATION AS OF 08-MAY-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED AND PASSED. CORRECTED SECTIONS AS OF 08-MAY-2020: H3: DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION CORRECTED FROM "YES" TO "NO".

    Additional Manufacturer Narrative · 1

    METER AND TEST STRIPS WERE NOT RETURNED FOR INVESTIGATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-61: IMPROPER USE/MISHANDLED BY END USER. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 134, 107, 119 AND 80 MG/DL. WHEN CUSTOMER WAS PERFORMING BACK TO BACK TESTS, CUSTOMER WAS USING THE SAME HAND AND THE SAME BLOOD SAMPLE. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 118 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 117 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/27/2020 AND OPEN VIAL DATE IS 09/24/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY; (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019441 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MW3385S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1