BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4844483 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00898
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 15, 2015
    Report Date
    December 22, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD AN INACCURATE REFERENCE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER'S SISTER IN LAW STATES THAT THE CUSTOMER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-112MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE LIVINGROOM AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 168MG/DL AND 184MG/DL FASTING. REVIEWED METER MEMORY: CUSTOMER'S SISTER IN LAW IS CALLING STATING THAT CUSTOMER'S METER IS READING TOO HIGH, SHE STATES AFTER THE CUSTOMER WENT SWIMMING SHE STATES SHE OBTAINED 218MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER'S SISTER IN LAW STATES THAT THE CUSTOMER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-112MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/14/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE LIVINGROOM AND WERE FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 168MG/DL AND 184MG/DL FASTING. REVIEWED METER MEMORY: (B)(6). CUSTOMER'S SISTER IN LAW IS CALLING STATING THAT CUSTOMER'S METER IS READING TOO HIGH, SHE STATES AFTER THE CUSTOMER WENT SWIMMING SHE STATES SHE OBTAINED 218MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380768 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2179

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR