BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4824601 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00872
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 11, 2015
    Report Date
    January 5, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 TO 159 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. COMPARING BLOOD GLUCOSE TEST RESULTS FROM TRUETRACK METER TO TRUERESULT METER. BACK TO BACK BLOOD TEST PERFORMED DURING CALL ON (B)(6) 2015 PRODUCED TEST RESULTS OF 310 MG/DL USING TRUETRACK METER AND 212 MG/DL USING TRUERESULT METER. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:310MG/DL (B)(6) 2015 11:39AM; 2:123MG/DL (B)(6) 2015 11:36AM; 3:129MG/DL (B)(6) 2015 11:32AM; 4:244MG/DL (B)(6) 2015 11:07AM; 5:118MG/DL (B)(6) 2015 11:04AM; ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 TO 159 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. COMPARING BLOOD GLUCOSE TEST RESULTS FROM TRUETRACK METER TO TRUERESULT METER. BACK TO BACK BLOOD TEST PERFORMED DURING CALL ON (B)(6) 2015 PRODUCED TEST RESULTS OF 310 MG/DL USING TRUETRACK METER AND 212 MG/DL USING TRUERESULT METER. VERIFIED STORAGE OF PRODUCT IS INSTRUCTED SPECIFICATION,.TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 310MG/DL, (B)(6) 2015, 11:39 AM; : 310MG/DL, (B)(6) 2015, 11:39 AM; 123MG/DL, (B)(6) 2015, 11:36 AM; 244MG/DL, (B)(6) 2015, 11:07 AM; 118MG/DL, (B)(6) 2015, 11:04 AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363654 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4604

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR