BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 6438840 · Received March 28, 2017

    Report

    Report Number
    1000113657-2017-00567
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 2, 2017
    Report Date
    April 26, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00087701405570
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. TEST STRIP UDI# (B)(4).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. TEST STRIP (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 122, 151 AND 147MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 110 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 198 MG/DL AND 149 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS (B)(6) 2016 (NO EXACT DATE TO VERIFY IF STRIPS WERE EXPIRED - FOUR MONTHS PAST DATE FIRST OPENED). CUSTOMER STATED THAT SHE HAS NOT HAD ANY CHANGES TO HER EXERCISE AND DIET ROUTINE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): THE 122MG/DL (B)(6) 2017 11:32 AM FASTING:YES, THE 151MG/DL (B)(6) 2017 11:28 AM FASTING:YES, THE 147MG/DL (B)(6) 2017 10:46 AM FASTING:YES, THE 134MG/DL (B)(6) 2017 02:38 PM FASTING:YES, THE 190MG/DL (B)(6) 2017 01:39 AM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH THE 122, 151, 147, 134 AND 190 MG/DL RESULTS FROM HER METER.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 122, 151 AND 147 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 110 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 198 MG/DL AND 149 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS (B)(6) 2016 (NO EXACT DATE TO VERIFY IF STRIPS WERE EXPIRED - FOUR MONTHS PAST DATE FIRST OPENED). CUSTOMER STATED THAT SHE HAS NOT HAD ANY CHANGES TO HER EXERCISE AND DIET ROUTINE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223402 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RT4922 00087701405570

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY