BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4894451 · Received July 1, 2015

    Report

    Report Number
    1052693-2015-01059
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 1, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED FOR EVALUATION: NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 TO 145 MG/DL. TESTING PERFORMED TWICE DAILY; MORNING AND NIGHT. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST DECLINED AT TIME OF CALL ON (B)(6) 2015. CURRENTLY TAKING INSULIN TO MANAGE DIABETES. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN LIVING ROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 275MG/DL (B)(6) 2015 11:48AM FASTING:YES; 302MG/DL (B)(6) 2015 11:47AM FASTING:NO; 237MG/DL (B)(6) 2015 11:37AM FASTING:YES; 267MG/DL (B)(6) 2015 11:11AM FASTING:YES; 283MG/DL (B)(6) 2015 10:21AM FASTING:YES; ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429357 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RS4581

    Patients

    Seq Age Sex Outcome Treatment
    1