BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5124678 · Received October 2, 2015

    Report

    Report Number
    1052693-2015-01855
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 9, 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
    CA
    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 HI RESULT. CUSTOMER STATES HE FEELS DIZZY, HAS CRAMPS AND GOING TO THE RESTROOM EVERY 30 MINUTES. CUSTOMER IS VERY THIRSTY AND SWEATING A LOT. CUSTOMER WILL SEEK MEDICAL ATTENTION. CUSTOMER IS CONCERNED WITH RESULTS OBTAINED. 1:TRUE RESULT HI (B)(6) 2015 08:25:00 PM NOT FASTING. 2:TRUE RESULT HI (B)(6) 2015 08:25:00 PM NOT FASTING. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULT. CUSTOMER STATES HE FEELS DIZZY, HAS CRAMPS AND GOING TO THE RESTROOM EVERY 30 MINUTES. CUSTOMER IS VERY THIRSTY AND SWEATING A LOT. CUSTOMER WILL SEEK MEDICAL ATTENTION. CUSTOMER IS CONCERNED WITH RESULTS OBTAINED. TRUE RESULT HI (B)(6) 2015 08:25:00 PM NOT FASTING. TRUE RESULT HI (B)(6) 2015 08:25:00 PM NOT FASTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652470 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2007

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR