BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4824680 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00836
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 5, 2015
    Report Date
    January 5, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    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

    CONSUMER COMPLAINT OF HIGH CONTROL SOLUTION TEST RESULTS. CUSTOMER'S HUSBAND STATES THAT HIS WIFE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 115-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 09/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 167MG/DL AND 99 MG/DL FASTING. REVIEWED METER MEMORY: 1: 104MG/DL, (B)(6) 2015, 11:07:00 PM, FASTING; 2: 102MG/DL, (B)(6) 2015, 01:15:00 PM, FASTING: YES; 3: 65MG/DL, (B)(6) 2015, 11:21:00 PM, FASTING: YES; 4: 67MG/DL, (B)(6) 2015, 11:05:00 PM, FASTING: YES; 5: 69MG/DL, (B)(6) 2015, 11:25:00 PM, FASTING: YES; NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH CONTROL SOLUTION TEST RESULTS. CUSTOMER'S HUSBAND STATES THAT HIS WIFE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 115-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 09/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 167MG/DL AND 99MG/DL FASTING. REVIEWED METER MEMORY: 1:104MG/DL (B)(6) 2015 11:07:00 PM FASTING:YES; 2:102MG/DL (B)(6) 2015 01:15:00 PM FASTING:YES; 3:65MG/DL (B)(6) 2015 11:21:00 PM FASTING:YES; 4:67MG/DL (B)(6) 2015 11:05:00 PM FASTING:YES; 5:69MG/DL (B)(6) 2015 11:25:00 PM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363729 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2125

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR