BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9628009 · Received January 24, 2020

    Report

    Report Number
    1000113657-2020-00051
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 24, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. 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. NOTE: ADVERSE EVENT REPORTED BASED ON THE CUSTOMER SEEKING MEDICAL ATTENTION DUE TO THE HIGH BLOOD GLUCOSE RESULTS OBTAINED.

    Description of Event or Problem · 1

    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 RESULTS OBTAINED OF 183, 177, 178 AND 175 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 137 - 150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. ON (B)(6) 2019 CUSTOMER WENT TO THE DOCTOR'S OFFICE DUE TO THE HIGH RESULT OBTAINED OF 177 MG/DL. CUSTOMER DID NOT REPORT HAVING ANY SYMPTOMS AT THE TIME. AT THE DOCTOR'S OFFICE, THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT USING THE METER WAS 170 MG/DL AND 143 MG/DL USING THE DOCTOR'S DEVICE; TESTS WERE PERFORMED WITHIN TWO MINUTES. THERE WAS NO DIAGNOSIS AND CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT. NO CHANGES TO THE CUSTOMER'S MEDICAL TREATMENT PLAN WERE RECOMMENDED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER NOT ABLE TO PRODUCE SUFFICIENT BLOOD SAMPLE TO CONDUCT BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2021 AND OPEN VIAL DATE IS (B)(6) 2019. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89882 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, SUNMARK TMX 50CTMG/DL MW3502S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other