BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5080320 · Received September 16, 2015

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    Report

    Report Number
    1052693-2015-01506
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 26, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT#: (B)(4). PRODUCT RETURNED FOR EVALUATION: NO PROBLEM FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIP ISSUE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT# (B)(4). PRODUCT RETURNED FOR EVALUATION: NO PROBLEM FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULT. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. VERIFIED THE STRIPS EXPIRE 05/19/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED IN (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND HI FASTING. REVIEWED METER MEMORY: HI: (B)(6) 2015, 11:42AM, FASTING . CUSTOMER CALLED STATING THEY ARE RECEIVING AN HI MESSAGE ON (B)(6) 2015, FASTING AT 11:42AM. THE CUSTOMER HAS BEEN PRESCRIBED INSULIN, BUT STATES THAT SHE DOES NOT USE THE MEDICATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. VERIFIED THE STRIPS EXPIRE 05/19/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED IN (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND HI FASTING. REVIEWED METER MEMORY: HI (B)(6) 2015 11:42AM FASTING. CUSTOMER CALLED STATING THEY ARE RECEIVING AN HI MESSAGE ON (B)(6) 2015, FASTING AT 11:42AM. THE CUSTOMER HAS BEEN PRESCRIBED INSULIN, BUT STATES THAT SHE DOES NOT USE THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611011 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4560

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR