BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792563 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00466
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 29, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED FOR EVALUATION: NO DEFECT FOUND WITH THE RETURNED STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE FOR THIS COMPLAINT IS USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-140MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/18/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BLOOD TEST, 187MG/DL NOT FASTING. REVIEWED METER MEMORY: (B)(6). TIME AND DATE WAS NOT SET CORRECTLY IN HER METER. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-140MG/DL. VERIFIED THE STRIPS EXPIRE 11/18/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BLOOD TEST; 187MG/DL NOT FASTING. REVIEWED METER MEMORY: 205MG/DL; (B)(6) 2015; 06:40:00 PM FASTING: NO, 137MG/DL (B)(6) 2015; 09:37:00 PM FASTING: NO, 150MG/DL (B)(6) 2015; 07:21:00 PM FASTING: NO, 176MG/DL (B)(6) 2015; 06:54:00 PM FASTING: NO,170MG/DL (B)(6) 2015; 097:11:00 PM FASTING: NO, 205MG/DL. TIME AND DATE NOT SET CORRECTLY IN HER METER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280878 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1713

    Patients

    Seq Age Sex Outcome Treatment
    1