BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8046199 · Received November 7, 2018

    Report

    Report Number
    1000113657-2018-01142
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 7, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. 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. TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 10/22/2018 IN A FOLLOW-UP CALL TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER'S CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. ADDITIONAL BLOOD TESTS WERE PERFORMED USING THE TRUEMETRIX METER AND CUSTOMER STATED METER IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 114, 113, 109, 147 AND 104 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 350 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER STATED THAT HE HAD A HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED HE WAS USING CORRECT TESTING TECHNIQUE. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885314 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2787 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR