BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5162641 · Received October 20, 2015

    Report

    Report Number
    1052693-2015-02026
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 28, 2015
    Report Date
    December 4, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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: STRIP ISSUE. ADDITIONAL PRODUCT CODES ADDED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF "LO" RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE UNKNOWN. VERIFIED TEST STRIPS EXPIRE 10/31/2016. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE IS (B)(6) 2015. REVIEWED METER MEMORY: LO MG/DL (B)(6) 2015 12:51:00 PM FASTING:YES. CUSTOMERS CONCERN: "LO" ON (B)(6) 2015. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF "LO"RESULTS. CUSTOMER STATES THAT HE FEELS PHYSICALLY FINE AND DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE UNKNOWN. VERIFIED TEST STRIPS EXPIRE 10/31/2016. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE IS (B)(6) 2015. REVIEWED METER MEMORY: LO (B)(6) 2015 12:51:00 PM FASTING:YES. CUSTOMERS CONCERN":LO" ON (B)(6) 2015. NO ADVERSE EVENT REPORTED. CUSTOMER CALLED REQUESTING ASSISTANCE WITH NEW METER AS SHE KEPT RECEIVING E-3 ERROR MESSAGE. SHE RETESTED OBTAINING A RESULT OF "LO". WHEN RETRIEVING METER MEMORY CUSTOMER ONLY HAD ONE RESULT IN METER MEMORY; CUSTOMER HAD TROUBLE RUNNING BACK TO BACK BLOOD TESTS AND KEPT RECEIVING E-2. UNABLE TO OBTAIN BACK TO BACK RESULTS. CUSTOMER IS A NEW PREDIABETIC IS UNSURE OF WHAT HER EXPECTED RESULTS SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691345 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1678

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR