BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5057965 · Received September 4, 2015

    Report

    Report Number
    1052693-2015-01624
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 13, 2015
    Report Date
    December 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES SHE FEELS WELL AND NO MEDICAL ATTENTION IS NEEDED. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 89-109MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 180MG/DL AND 168MG/DL. REVIEWED METER MEMORY: 1:194MG/DL (B)(6) 2014 03:49:00 PM FASTING:YES. 2:177MG/DL (B)(6) 2014 01:18:00 AM FASTING:YES . 3:162MG/DL (B)(6) 2014 09:05:00 AM FASTING:YES. 4:129MG/DL (B)(6) 2014 07:06:00 AM FASTING:YES. 5:193MG/DL (B)(6) 2014 04:45:00 AM FASTING:YES. CUSTOMER IS CONCERN WITH THE RESULTS SHE HAVE BEEN GETTING FOR THE PAST FEW DAYS BUT ESPECIALLY TEST TAKEN TODAY (B)(6) 2014; 162/177/194MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES SHE FEELS WELL AND NO MEDICAL ATTENTION IS NEEDED. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 89-109MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 180MG/DL AND 168MG/DL. REVIEWED METER MEMORY: (B)(6). CUSTOMER IS CONCERN WITH THE RESULTS SHE HAVE BEEN GETTING FOR THE PAST FEW DAYS BUT ESPECIALLY TEST TAKEN TODAY (B)(6) 2014; 162/177/194MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588037 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2167

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR