BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5033243 · Received August 26, 2015

    Report

    Report Number
    1052693-2015-01495
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    October 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. CUSTOMER NORMALLY READS 89-120MG/DL BUT HAS BEEN CURRENTLY READING IN THE 400'S. CUSTOMER STATES HE FEELS FINE. DENIES ANY SYMPTOMS OF HIGH BLOOD SUGAR, DENIES NEED FOR MEDICAL ATTENTION. STRIP EXPIRATION DATE:09/26/2017. STRIP OPEN DATE: (B)(6) 2015. STRIP STORAGE:YES, STORED CORRECTLY. BACK TO BACK BLOOD GLUCOSE TESTING PERFORMED WITH RESULTS: BLOOD TEST 1: 130MG/DL FASTING:YES. BLOOD TEST 2: 120MG/DL FASTING:YES. REVIEWED METER MEMORY: 1: 332MG/DL (B)(6) 2015 07:27:00 AM FASTING:YES. 2: 365MG/DL (B)(6) 2015 07:44:00 PM FASTING:NO. 3: 220MG/DL (B)(6) 2015 07:58:00 AM FASTING:YES. 4: 361MG/DL (B)(6) 2015 07:48:00 AM FASTING:YES. 5 :228MG/DL (B)(6) 2015 05:04:00 PM FASTING:YES. CUSTOMERS CONCERN:365MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. CUSTOMER NORMALLY READS 89-120MG/DL BUT HAS BEEN CURRENTLY READING IN THE 400'S. CUSTOMER STATES HE FEELS FINE. DENIES ANY SYMPTOMS OF HIGH BLOOD SUGAR, DENIES NEED FOR MEDICAL ATTENTION. STRIP EXPIRATION DATE: 09/26/2017. STRIP OPEN DATE: (B)(6) 2015. STRIP STORAGE:YES, STORED CORRECTLY. BACK TO BACK BLOOD GLUCOSE TESTING PERFORMED WITH RESULTS: BLOOD TEST 1: 130MG/DL FASTING:YES. BLOOD TEST 2: 120MG/DL FASTING:YES. REVIEWED METER MEMORY: 332MG/DL (B)(6) 2015 07:27:00 AM FASTING:YES; 365MG/DL (B)(6) 2015 07:44:00 PM FASTING:NO; 220MG/DL (B)(6) 2015 07:58:00 AM FASTING:YES; 361MG/DL (B)(6) 2015 07:48:00 AM FASTING:YES; :228MG/DL (B)(6) 2015 05:04:00 PM FASTING:YES; CUSTOMERS CONCERN: 365MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564826 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2111

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR