BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUERESULT

    MDR report key: 4792561 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00472
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    January 6, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER HAS LOW GLUCOSE VALUE. PRODUCT CODES UPDATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". THE CUSTOMER'S DAUGHTER STATES MOTHER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 88-115MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, LO AND LO BOT FASTING. REVIEWED METER MEMORY: 103MG/DL; (B)(6) 2015; 04:40:00PM, FASTING: YES, LO MG/DL (B)(6) 2015; 01:01:00 PM; FASTING : YES, LO MG/DL (B)(6) 2015; 01:01:00 PM; FASTING : YES, LO MG/DL (B)(6) 2015; 10:20:00 PM; FASTING : YES, 145 MG/DL (B)(6) 2015; 09:50:00 PM; FASTING : YES,. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". THE CUSTOMER'S DAUGHTER STATES MOTHER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 88-115MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, LO AND LO BOT FASTING. REVIEWED METER MEMORY: (B)(6). THE TIME AND DATE ON THE METER ARE NOT SET. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280521 RUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2167

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR