BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6698761 · Received July 10, 2017

    Report

    Report Number
    1000113657-2017-01331
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    August 31, 2015
    Report Date
    July 10, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (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. BASED ON REVIEW WITH FDA ON 06/21/2017, WE VERIFIED THE AGENCY'S INTERPRETATION OF THE ACT AND SUBMIT THIS MEDWATCH REPORT BASED ON THE NATURE OF THE COMPLAINT FOR THIS RECALLED LOT. FDA-ASSIGNED RECALL EVENT ID 74805.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED BECAUSE OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON FASTING AND PRODUCED TEST RESULTS OF 178 AND 175 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/20/2018 AND OPEN VIAL DATE IS (B)(6) 2015. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 140MG/DL (B)(6) 2015 10:09:00 AM FASTING:YES, THE 144MG/DL (B)(6) 2015 09:35:00 PM FASTING:YES, THE 138MG/DL (B)(6) 2015 09:34:00 PM FASTING:YES, THE 137MG/DL (B)(6) 2105 09:33:00 PM FASTING:YES, THE 165MG/DL (B)(6) 2015 09:29:00 PM FASTING:YES. CUSTOMERS CONCERN:CUSTOMER IS CONCERN WITH ALL THE RESULTS IN THE METER BECAUSE IT IS CONSISTANLY RUNS 40 POINTS LOWER WHEN COMAPRED TO HIS ACCUCHECK METER. METER TO METER COMPARISON: ANOTHER DEVICE 154 (B)(6) 2015 08:30:00 PM FASTING, TRUE RESULT 140 (B)(6) 2015 10:09:00 PM FASTING. CUSTOMER CALLING STATES THAT THE METER IS NOT GIVING ACCURATE BLOOD RESULTS. THE METER IS GIVING 40-50 POINTS LOWER WHEN COMPARED TO THE ACCU-CHEK METER. CUSTOMER HAVE ONLY BEEN USING THE METER FOR ABOUT A WEEK NOW AND IS NOT SATISFIED WITH THE LOWER RESULTS HE IS GETTING. CUSTOMER NORMAL GLUCOSE RANGE IS 140 MG/DL AND HE TEST 3 TIMES A DAY. CUSTOMER STATES THAT THESE RESULTS COMPARE TO HIS A1C TEST THAT WAS TAKEN LESS THAN A MONTH AGO ARE A LOT LOWER. CHECK CUSTOMER ACCU-CHEK MEMORY ON (B)(6) 2015 9:30PM 154, ON (B)(6) 2015 5:47AM 160, ON (B)(6) 2015 9:04PM 202, ON (B)(6) 2015 5:55AM 159, ON (B)(6) 2015 9:22PM 136. RUN BLOOD TEST AND GOT 175M/DL WITH THE TRUERESULT METER AND THEN WITH THE ACCU-CHEK METER RESULTS WAS 212MG/DL. CUSTOMER BELIEVES THE ACCU-CHEK RESULT IS BETTER BECAUSE HE JUST ATE SOME CHIPS. I WILL REPLACE THE METER, STRIPS AND SEND CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477692 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2270

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR