BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5148181 · Received October 14, 2015

    Report

    Report Number
    1052693-2015-01983
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 23, 2015
    Report Date
    December 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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'S TEST STRIP WAS STORED IN POOR STORAGE CONDITIONS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES HE FEELS WELL AND DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE FIRST OPENED 08/23/2015. REVIEWED METER MEMORY (B)(6). CUSTOMERS CONCERN: 213, 262, 228 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES HE FEELS WELL AND DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN:213, 262, 228 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679225 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2347

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR