BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 5960230 · Received September 19, 2016

    Report

    Report Number
    1000113657-2016-01572
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    August 26, 2016
    Report Date
    October 13, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER AND RETURNED TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TEST OF 221, 209 AND 161 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-150 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER IS AT SCHOOL. UNABLE TO VERIFY IF HE IS SYMPTOMATIC. CUSTOMER'S MOTHER WAS TRAINED ON PROPER BACK TO BACK TESTING TECHNIQUE. RESULT FROM CONTROL SOLUTION IS WITHIN NORMAL RANGE.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TEST OF 221, 209 AND 161 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-150 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER IS AT SCHOOL. UNABLE TO VERIFY IF HE IS SYMPTOMATIC. CUSTOMER'S MOTHER WAS TRAINED ON PROPER BACK TO BACK TESTING TECHNIQUE. RESULT FROM CONTROL SOLUTION IS WITHIN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611228 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1573

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY