BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5098955 · Received September 23, 2015

    Report

    Report Number
    1052693-2015-01777
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    September 1, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. THE MOST LIKELY UNDERLYING ROOT CAUSE OF THIS MALFUNCTION WAS IDENTIFIED AS A STRIP ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES HE FEELS WELL AND STATES HE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-130MG/DL. VERIFIED THE STRIPS EXPIRE 01/16/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED IN (B)(6) 2015. REVIEWED METER MEMORY: LO 09/01/2015 07:00:00 AM FASTING:YES 127MG/DL, (B)(6) 2015 07:00:00 AM, FASTING: NO. 125MG/DL, (B)(6) 2015 07:00:00 AM, FASTING: YES. 101MG/DL, (B)(6) 2015 07:00:00 AM, FASTING: YES. 113MG/DL, (B)(6) 2015 07:00:00 AM, FASTING: YES. CUSTOMERS CONCERN: LO (B)(6) 2015 7:00AM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES HE FEELS WELL AND STATES HE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-130MG/DL. VERIFIED THE STRIPS EXPIRE 01/16/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED IN (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN: LO (B)(6) 2015 7:00AM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629686 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2201

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR