BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4502631 · Received February 6, 2015

    Report

    Report Number
    1052693-2015-00092
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    December 22, 2014
    Report Date
    January 6, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION NOTED IN THE COMPLAINT: USER HAD INACCURATE REFERENCE, USER'S TEST STRIPS HAD POOR STORAGE. MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (07/07/2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER STATES THAT THE VIALS OF STRIPS ARE STORED IN THE BEDROOM. RAN A BLOOD TEST USING A CAPILLARY BLOOD SAMPLE, 220 MG/DL. EXPECTED BLOOD RESULTS FASTING IS 100 MG/DL-120 MG/DL. REVIEWED THE LAST 5 BLOOD IN THE METER MEMORY: (B)(6) 2014 @8:30PM 179MG/DL, (B)(6) 2014 @ 10:14AM 141 MG/DL, (B)(6) 2014 @ 11:15 PM 551 MG/DL, (B)(6) 2014 @ 12:17 PM 250MG/DL, (B)(6) 2014 @ 11:48 PM 351 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85774 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4531

    Patients

    Seq Age Sex Outcome Treatment
    1