BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5964158 · Received September 20, 2016

    Report

    Report Number
    1000113657-2016-01590
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 29, 2016
    Report Date
    October 13, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH DEFECT FOUND ON BATTERY CONTACT (BATTERY TERMINAL) DAMAGED. MANUFACTURER HAS TAKEN CORRECTIVE ACTION TO ELIMINATE THIS ISSUE. REF: (B)(4). UNABLE TO CONFIRM COMPLAINT DUE TO BATTERY CONTACT DAMAGE.

    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.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS COMPARED TO ANOTHER BRAND METER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON AND RESULTS OBTAINED OF 182 AND 253MG/DL ON ANOTHER METER BRAND. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 140 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON FASTING AND PRODUCED TEST RESULTS OF 366 AND 328 MG/DL USING TRUE RESULT METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS "01/22/20198" AND OPEN VIAL DATE IS (B)(4) 2016 THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(4). BACK TO BACK BLOOD TEST WITH THE CUSTOMER WITH A BLOOD RESULT OF 366 MG/DL NON FASTING AND THEN 328 MG/DL NON FASTING IMMEDIATELY AFTER. IT IS OBSERVED,CUSTOMER OBTAINED HIGH RESULTS ON METER'S MEMORY OUTSIDE OF EXPECTED RESULTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS COMPARED TO ANOTHER BRAND METER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON AND RESULTS OBTAINED OF 182 AND 253MG/DL ON ANOTHER METER BRAND. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 140 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON FASTING AND PRODUCED TEST RESULTS OF 366 AND 328 MG/DL USING TRUE RESULT METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/22/20198 AND OPEN VIAL DATE IS (B)(6) 2016 THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). MEMORY CONCERNS:182 MG/DL BACK TO BACK BLOOD TEST WITH THE CUSTOMER WITH A BLOOD RESULT OF 366 MG/DL NON FASTING AND THEN 328 MG/DL NON FASTING IMMEDIATELY AFTER. IT IS OBSERVED,CUSTOMER OBTAINED HIGH RESULTS ON METER'S MEMORY OUTSIDE OF EXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614615 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2647

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY