BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5163098 · Received October 20, 2015

    Report

    Report Number
    1052693-2015-02045
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 29, 2015
    Report Date
    December 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-120MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 08/26/2017. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE IS (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 197MG/DL AND 217MG/DL REVIEWED METER MEMORY: (B)(4). CUSTOMERS CONCERN: 171, 191, 249, 253MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-120MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 08/26/2017. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE IS (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 197MG/DL AND 217MG/DL REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN: 171, 191, 249, 253MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692796 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BS4621

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR