BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4824682 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00834
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 5, 2015
    Report Date
    December 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD AN INACCURATE REFERENCE OR USER REUSED TEST STRIP OR USER'S TEST STRIP HAD POOR FILL. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 115-150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST. 91MG/DL AND 93MG/DL FASTING. REVIEWED METER MEMORY: 1: 65MG/DL, (B)(6) 2015, 11:41:55 AM, FASTING: NO; 2: 63MG/DL, (B)(6) 2015, 11:41:55 AM, FASTING: NO; 3: 105MG/DL, (B)(6) 2015, 11:41:55 AM, FASTING: YES; 4: 91MG/DL, (B)(6) 2015, 11:41:55 AM, FASTING: YES; 5: 109MG/DL, (B)(6) 2015, 11:41:55 AM, FASTING: YES.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 115-150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 91MG/DL AND 93MG/DL FASTING. REVIEWED METER MEMORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363890 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2183

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR