BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5100578 · Received September 24, 2015

    Report

    Report Number
    1052693-2015-01783
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 27, 2015
    Report Date
    December 31, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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: USER HAD AN INACCURATE REFERENCE.

    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 90-120MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 06/16/2018. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY, AND OPENED VIAL DATE IS 08/24/2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 158MG/DL AND 158MG/DL BOTH TIMES. REVIEWED METER MEMORY (B)(6). CUSTOMER IS COMPARING HIS TRUERESULT METER TO HIS BROTHERS TRUERESULT METER. HE RAN A BLOOD GLUCOSE TEST ON (B)(6) 2015 @9AM (FASTING) ON HIS TRUERESULT METER HE GOT 55MG/DL AND HIS BROTHERS TRUERESULT METER GAVE HIM 79MG/DL. 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 90-120MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 06/16/2018. 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 158MG/DL AND 158MG/DL BOTH TIMES. REVIEWED METER MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631773 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT REPLACED F

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR