BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5124681 · Received October 2, 2015

    Report

    Report Number
    1052693-2015-01858
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 8, 2015
    Report Date
    December 10, 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. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: THE USER'S TEST STRIP WAS STORED IN POOR STORAGE CONDITIONS.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-112MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 07/22/2018. CUSTOMER'S TEST STRIPS ARE BEING STORED IN THE KITCHEN AND OPENED VIAL DATE IS (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-112MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 07/22/2018. CUSTOMER'S TEST STRIPS ARE BEING STORED IN THE KITCHEN AND OPENED VIAL DATE IS (B)(6) 2015. REVIEWED METER MEMORY (B)(6). NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653420 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2420

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR