BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5014437 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01490
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 25, 2015
    Report Date
    December 8, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION STRIP ISSUE INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT "HI" BLOOD RESULTS. CUSTOMER'S DAUGHTER STATES THAT HER MOM FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 300-400MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/21/2017. CUSTOMER CONFIRMS THE STRIPS ARE PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 581MG/DL AND 567MG/DL. REVIEWED METER MEMORY: 1: HI, (B)(6) 2015, 07:22:00 PM, FASTING:YES; 2: HI, (B)(6) 2015, 01:30:00 AM, FASTING:YES; 3: HI, (B)(6) 2015, 10:39:00 PM, FASTING:YES; 4: 458MG/DL, (B)(6) 2015, 10:16:00 AM, FASTING:YES; 5: 325MG/DL, (B)(6) 2015, 11:32:00 AM, FASTING:YES. CUSTOMER'S CONCERN: HI ON (B)(6) 2015 AT 7:22 PM, HI ON (B)(6) 2015 AT 7:22 PM, AND HI ON (B)(6) 2015 AT 10:39 PM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT "HI" BLOOD RESULTS. CUSTOMER'S DAUGHTER STATES THAT HER MOM FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 300-400MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/21/2017. CUSTOMER CONFIRMS THE STRIPS ARE PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 581MG/DL AND 567MG/DL REVIEWED METER MEMORY: HI, (B)(6) 2015 07:22:00 PM, FASTING: YES. HI, (B)(6) 2015 01:30:00 AM, FASTING: YES. HI, (B)(6) 2015 10:39:00 PM, FASTING: YES. 458MG/DL, (B)(6) 2015 10:16:00 AM, FASTING: YES. 325MG/DL, (B)(6) 2015 11:32:00 AM, FASTING: YES. CUSTOMERS CONCERN: HI ON (B)(6) 2015 AT 7:22 PM, HI ON (B)(6) 2015 AT 7:22 PM, AND HI ON (B)(6)2015 AT 10:39 PM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533190 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2011

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR