BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792496 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00478
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    January 6, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "LO". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-105MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/15/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN CABINET AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: LO MG/DL, (B)(6) 2015, 11:09:00 AM, FASTING: YES; LO MG/DL, (B)(6) 2015, 07:29:00 AM, FASTING: YES; 126MG/DL, (B)(6) 2015, 07:28:00 AM, FASTING: YES; 110MG/DL, (B)(6) 2015, 07:51:00 AM, FASTING: YES; 93MG/DL, (B)(6) 2015, 08:00:00 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "LO". CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 90-105MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/15/2017. (B)(6) 2015. REVIEWED METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280349 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4576

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR