BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5976777 · Received September 26, 2016

    Report

    Report Number
    1000113657-2016-01635
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 4, 2016
    Report Date
    November 21, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER IS TESTING WITH EXPIRED TEST STRIPS. VIAL LOT OPENED OVER SIX MONTHS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT SYSTEM EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIPS HAD A POOR FILL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S SON, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 100 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/15/2017 AND OPEN VIAL DATE IS OPEN OVER SIX MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER HAS NOT HAD ANY CHANGES IN THE DIET. CUSTOMER STATED THAT SHARES THE METER WITH THE WIFE. CUSTOMER'S SON WAS ADVISE THAT THE FATHER SHOULD NOT SHARE THE METER WITH ANYONE. UNABLE TO PERFORM A BACK TO BACK BLOOD TEST AS THE TEST STRIPS HAS BEEN OPEN OVER 6 MONTHS. THE CUSTOMER WAS ADVISED THE TEST STRIPS ARE ONLY GOOD FOR 4 MONTHS AFTER BEING OPEN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S SON, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 100 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/15/2017 AND OPEN VIAL DATE IS OPEN OVER SIX MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER HAS NOT HAD ANY CHANGES IN THE DIET. CUSTOMER STATED THAT SHARES THE METER WITH THE WIFE. CUSTOMER'S SON WAS ADVISED THAT THE FATHER SHOULD NOT SHARE THE METER WITH ANYONE. UNABLE TO PERFORM A BACK TO BACK BLOOD TEST AS THE TEST STRIPS HAS BEEN OPEN OVER 6 MONTHS. THE CUSTOMER WAS ADVISED THE TEST STRIPS ARE ONLY GOOD FOR 4 MONTHS AFTER BEING OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628701 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PR2069

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY