BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4894467 · Received July 1, 2015

    Report

    Report Number
    1052693-2015-01048
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT UNDER EVALUATION.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/23/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 94MG/DL AND 94MG/DL FASTING. REVIEWED METER MEMORY: 1: 192MG/DL (B)(6) 2015 09:28:00 PM FASTING: YES. 2: 119MG/DL (B)(6) 2015 09:28:00 PM FASTING: YES. 3: 119MG/DL (B)(6) 2015 09:01:00 PM FASTING: YES. 4: 103MG/DL (B)(6) 2015 08:41:00 PM FASTING: YES. 5: 190MG/DL (B)(6) 2015 07:05:00 PM FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/23/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 94MG/DL AND 94MG/DL FASTING. REVIEWED METER MEMORY: 192MG/DL, (B)(6) 2015 09:28:00 PM, FASTING: YES. 119MG/DL, (B)(6) 2015 09:28:00 PM, FASTING: YES. 119MG/DL, (B)(6) 2015 09:01:00 PM, FASTING: YES. 103MG/DL, (B)(6) 2015 08:41:00 PM, FASTING: YES. 190MG/DL, (B)(6) 2015 07:05:00 PM, FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429684 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2290

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR