BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4762648 · Received May 7, 2015

    Report

    Report Number
    1052693-2015-00699
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 17, 2015
    Report Date
    May 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER'S WIFE STATES THAT HER HUSBAND FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 140-210 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/30/2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 260 MG/DL AND 276 MG/DL FASTING. REVIEWED METER MEMORY: 286 MG/DL (B)(6) 2015 01:58:00 PM FASTING: YES; 250 MG/DL (B)(6) 2015 01:56:00 PM FASTING: YES; 289 MG/DL (B)(6) 2015 01:48:10 PM FASTING: YES; 302 MG/DL (B)(6) 2015 01:46:10 PM FASTING: YES; 317 MG/DL (B)(6) 2015 01:45:10 PM FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299865 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC. TRUETRACK RN4055

    Patients

    Seq Age Sex Outcome Treatment
    1