BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5470461 · Received March 1, 2016

    Report

    Report Number
    1052693-2016-00397
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 1, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES THAT SHE FEELS PHYSICALLY FINE, DENIES THE NEED FOR MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 115-130MG/DL FASTING. VERIFIED TEST STRIPS EXPIRE 02/15/2018. CONFIRMED CUSTOMER'S TEST STRIPS ARE BEING STORED PROPERLY AND OPENED VIAL DATE (B)(6) 2016. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST 245MG/DL AND 262MG/DL NON-FASTING. REVIEWED METER MEMORY: (B)(6). MEMORY CONCERNS: WITH 435MG/DL ON (B)(6) 2016 10:50:00 PM AND 280MG/DL ON (B)(6) 2016 10:53:00 PM 396MG/DL ON (B)(6) 2016 10:55:00 PM. THE DATE IS SET PROPERLY ON THE METER AND TIME IS ONE HOUR OFF. THE CUSTOMER HAD CONTROL SOLUTION WHICH WAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126607 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4753

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR