BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4844484 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00897
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 15, 2015
    Report Date
    December 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 101-125MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/21/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 135MG/DL AND 151MG/DL FASTING. REVIEWED METER MEMORY. CUSTOMER STATES HE TESTED HIS BLOOD GLUCOSE 45 MINUTES AFTER EATING A SANDWICH. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 101-125MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/21/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 135MG/DL AND 151MG/DL FASTING. REVIEWED METER MEMORY: (B)(6). CUSTOMER STATES HE TESTED HIS BLOOD GLUCOSE 45 MINUTES AFTER EATING A SANDWICH. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381013 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PR2075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR