BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4844482 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00901
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 16, 2015
    Report Date
    June 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT#: (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: USER HAS HIGH GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER'S MOTHER STATES THAT HER SON FEELS VERY TIRED BUT STATES HE REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 145-150MG/DL FASTING. VERIFIED THE STRIP EXPIRE 09/29/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY, THE CUSTOMER STATES THE STRIPS WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BLOOD TEST AND OBTAINED HI-FASTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381025 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PS2113

    Patients

    Seq Age Sex Outcome Treatment
    1