BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5654504 · Received May 13, 2016

    Report

    Report Number
    1052693-2016-00934
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 26, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND ON RETURNED METER AND TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 180MG/DL FASTING. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/22/2016 AND OPEN VIAL DATE IS (B)(6) 2016. THE PRODUCT IS STORED IN THE KITCHEN. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED FASTING OF 500MG/DL ON (B)(6) 2016 06:39:00 PM; 450MG/DL ON (B)(6) 2016 06:41:00 PM; 400MG/DL ON (B)(6) 2016 06:44:00 PM. REVIEWED METER MEMORY: (B)(6). SHE RAN A BLOOD GLUCOSE TEST ON (B)(6) 2016 AT 6:39PM TWO HOURS AFTER HER DINNER AND HER RESULT WAS 500MG/DL. CUSTOMER STATED THAT HER RANGE (NONFASTING) HAS TO BE LESS THAN-180MG/DL AS PER HER DIABETES EDUCATOR. CUSTOMER STATED THAT SHE WAS PRESCRIBED METFORMIN 2 TIMES A DAY BUT SHE IS NOT TAKING HER MEDICATIONS, SHE IS ALSO ON PREDNISONE EVERY MORNING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 180MG/DL FASTING. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/22/2016 AND OPEN VIAL DATE IS (B)(6) 2016. THE PRODUCT IS STORED IN THE KITCHEN. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED FASTING OF 500MG/DL ON (B)(6) 2016 06:39:00 PM; 450MG/DL ON (B)(6) 2016 06:41:00 PM; 400MG/DL ON (B)(6) 2016 06:44:00 PM. REVIEWED METER MEMORY: (B)(6). SHE RAN A BLOOD GLUCOSE TEST ON (B)(6) 2016 AT 6:39PM TWO HOURS AFTER HER DINNER AND HER RESULT WAS 500MG/DL. CUSTOMER STATED THAT HER RANGE (NONFASTING) HAS TO BE LESS THAN-180MG/DL AS PER HER DIABETES EDUCATOR. CUSTOMER STATED THAT SHE WAS PRESCRIBED METFORMIN 2 TIMES A DAY BUT SHE IS NOT TAKING HER MEDICATIONS, SHE IS ALSO ON PREDNISONE EVERY MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308459 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RS4806

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR