BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5014827 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01400
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. INTERNAL REPORT #(B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "LO". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-170MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 128MG/DL AND 140MG/DL FASTING. REVIEWED METER MEMORY: 130MG/DL (B)(6) 2015 12:29:00 AM FASTING: YES; 130MG/DL (B)(6) 2015 11:46:00 PM FASTING: YES; "LO" (B)(6) 2015 11:43:00 PM FASTING: YES; 125MG/DL (B)(6) 2015 11:21:00 PM FASTING: YES; 174MG/DL (B)(6) 2015 11:33:00 PM FASTING: YES. CUSTOMER CONCERN WITH LO ON (B)(6) 2015 11:43:00 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533196 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4673

    Patients

    Seq Age Sex Outcome Treatment
    1