BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5014461 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01492
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 25, 2015
    Report Date
    December 8, 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

    (B)(4). PRODUCT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD INCORRECT CODE KEY INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI." CUSTOMER STATES THAT SHE FEELS TIRED AND EXPRESSED THAT SHE WANTED TO LAY DOWN. THE CUSTOMER STATES THAT SHE DOES NOT REQUIRE MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 83-324MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND HI FASTING. REVIEWED METER MEMORY: 1: HI, (B)(6) 2015, 12:23:00 AM, FASTING: YES; 2: HI, (B)(6) 2015, 12:35:00 PM, FASTING: YES; 3: HI, (B)(6) 2015, 10:23:00, PM, FASTING: YES; 4: HI, (B)(6) 2015, 10:21:00 PM, FASTING: YES; 5: HI, (B)(6) 2015, 10:17:00, PM, FASTING:YES. CUSTOMER'S CONCERN: ALL THE HI RESULTS ARE CONCERNING THE CUSTOMER. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CUSTOMER STATES THAT SHE FEELS TIRED AND EXPRESSED THAT SHE WANTED TO LAY DOWN. THE CUSTOMER STATES THAT SHE DOES NOT REQUIRE MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 83-324MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED 07/11/2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND HI FASTING. REVIEWED METER MEMORY: 1:HI (B)(6) 2015 12:23:00 AM FASTING:YES. 2:HI (B)(6) 2015 12:35:00 PM FASTING:YES. 3:HI (B)(6) 2015 10:23:00 PM FASTING:YES. 4:HI (B)(6) 2015 10:21:00 PM FASTING:YES. 5:HI (B)(6) 2015 10:17:00 PM FASTING:YES. CUSTOMERS CONCERN:ALL THE HI RESULTS ARE CONCERNING THE CUSTOMER. NO ADVERSE EVENT REPORTED. S/N #(B)(4), MODEL #TRUETRACK. INVESTIGATION REQUIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535073 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4676

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR