BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9186584 · Received October 14, 2019

    Report

    Report Number
    1000113657-2019-10060
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 30, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION. DEFECT WAS DETECTED. MOST LIKELY UNDERLYING ROOT CAUSE: RC-61: STORAGE OUTSIDE SPECIFICATIONS. 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 HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 233, 251, 200, 179 AND 172 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 MG/DL. CUSTOMER STATED THE HIGH RESULTS STARTED ABOUT ONE WEEK AGO. 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; CUSTOMER HAD JUST TESTED PRIOR TO CALL AND HAD OBTAINED RESULT OF 233 MG/DL FASTING. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2020 AND OPEN VIAL DATE IS 09/16/2019. CUSTOMER HAD BEEN USING TEST STRIP LOT NUMBER MV3197, BUT HAD FINISHED THE VIAL OF STRIPS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978070 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MW3301S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1